Editor’s Note: This page is updated weekly with new information related to COVID-19 testing and potential treatments in development. Click the arrow next to the date to expand the text.
[section= May 27, 2020]
Results from the first potential COVID-19 vaccine to be tested in a Phase 1 clinical trial (NCT04313127) were recently published in the journal The Lancet. They showed that the adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine was tolerable and able to trigger an immune response as early as 14 days after vaccination. The researchers concluded that the potential vaccine is worth further investigation but cautioned that they are still a long way off from having a COVID-19 vaccine available to all.
Novavax is enrolling the first participants in a Phase 1/2 trial testing its vaccine candidate, NVX‑CoV2373. The trial is being conducted in two parts, the first of which is taking place in Australia and is testing the safety and immune response in healthy volunteers, ages 18 to 59. The Phase 2 portion will be conducted in multiple countries and will include a broader age range to test the vaccine’s safety, immunity, and ability to reduce COVID-19 disease.
Glenmark Pharmaceuticals is launching a Phase 3 trial in India to test if early treatment with favipiravir and umifenovir improves the efficacy of the antiviral combination in hospitalized COVID-19 patients. The trial is expected to enroll approximately 158 participants with moderate COVID-19, who will be randomized to receive favipiravir either with or without umifenovir, plus standard care.
Covis Pharma has announced the start of a Phase 3 trial (NCT04377711) to assess the safety and efficacy of the asthma medication Alvesco (ciclesonide) in people with symptoms of COVID-19, ages 12 and older who are not hospitalized. Researchers think the treatment may suppress viral replication and alleviate symptoms of the disease. The multicenter, randomized trial is expected to recruit 400 participants across the U.S. and is estimated to be completed by the end of the year.
A new trial (NCT04303507) led by the University of Oxford and the Mahidol Oxford Tropical Medicine Research Unit in Thailand is recruiting participants to test the effect of chloroquine and hydroxychloroquine on COVID-19. The randomized trial will enroll an estimated 40,000 healthcare workers across Europe, Africa, Asia, and South America who have had close contact with patients with either proven or suspected COVID-19. There is currently no conclusive proof that either chloroquine or hydroxychloroquine can prevent or treat COVID-19.
Octapharma is launching a Phase 3 trial to test whether Octagam 10%, its intravenous immune globulin therapy, can slow or prevent respiratory deterioration in COVID-19 patients.The multicenter, randomized trial will enroll 54 patients with severe COVID-19 at approximately 10 sites in the U.S. Octagam 10% is an approved treatment for chronic immune thrombocytopenic purpura in adults.
IMV has selected a vaccine candidate against COVID-19 that it plans to advance into in-human studies. The vaccine, called DPX-COVID-19, is based on peptide epitopes that showed robust immune and antibody responses in preclinical studies. The company anticipates launching a Phase 1 trial to test the potential vaccine this summer.
AstraZeneca has finalized agreements for the first 400 million doses of its vaccine candidate being developed by the University of Oxford. It has already secured manufacturing capacity for 1 billion doses and plans to begin the first deliveries in September. The vaccine, called AZD1222, (previously ChAdOx1 nCoV-19) is being tested in a Phase 1/2 trial (NCT04324606) to determine the safety, efficacy, and immune response in more than 1,000 healthy volunteers.
[section= May 20, 2020]
Moderna announced positive interim results from a Phase 1 clinical trial (NCT04283461) testing its potential COVID-19 vaccine mRNA-1273. The trial, led by the National Institutes of Health, is testing three different doses of mRNA-1273 in healthy volunteers ages 18–55 for safety, immune response, and adverse effects. The results so far show that the vaccine is generally safe and well tolerated. Moderna is planning a Phase 2 trial to further test the potential vaccine and determine the right dose to be used in pivotal studies expected to start in July. The Phase 1 trial is still recruiting healthy volunteers in Georgia, Maryland, and Washington.
NeuroRx is sponsoring a Phase 2b/3 trial (NCT04360096) that will test aviptadil in critically ill COVID-19 patients. The goal of the trial is to identify COVID-19 patients with non-acute lung injury and treat them with aviptadil in hopes of preventing progression from non-acute to acute lung injury and acute respiratory distress syndrome, or ARDS, both complications associated with COVID-19. The multicenter, randomized, placebo-controlled trial will recruit approximately 144 participants with COVID-19 and evidence of lung injury. Enrollment is not yet open.
Stanford Medicine is currently enrolling participants in a Phase 2 trial (NCT04331899) testing whether peginterferon lambda-1a can help patients to recover faster and limit viral shedding, which lowers the risk of transmission to others. The open-label, randomized trial is recruiting an estimated 120 participants in California, ages 18 to 64, with an initial diagnosis of COVID-19 and symptoms of respiratory infection without respiratory distress. Peginterferon lambda-1a is an antiviral that has already been tested against viruses that cause hepatitis.
The University of Oxford has launched a trial in the U.K. that will test the ability of existing treatments such as hydroxychloroquine and azithromycin to prevent, slow, or even halt the progression of COVID-19 and reduce the severity of its symptoms, avoiding hospital admissions in people older than 50.
The FDA completed its review of ViralClear’s investigational new drug application for merimepodib to treat adults with advanced COVID-19. This means the company can now start its proposed Phase 2 trial testing the potential treatment. The trial will be randomized, double blind, and placebo-controlled and is expected to be conducted at multiple sites across the U.S. It will test the safety and efficacy of merimepodib in adults infected with SARS-CoV-2 and admitted to the hospital requiring supplemental oxygen.
Interim results from a multicenter, randomized trial in Russia testing Avigan (favipiravir) showed that 60% of the 40 patients with COVID-19 who received the treatment tested negative for the virus after five days, according to the Russian Direct Investment Fund, which is financing the study. The trial is expected to include 330 participants with confirmed COVID-19 at sites across Russia. Avigan is an antiviral first developed in Japan for the treatment of influenza.
Results from an observational study in France show that hydroxychloroquine does not significantly lower admissions to intensive care or death in patients hospitalized with pneumonia due to COVID-19. In addition, a randomized trial in China found that patients with mild to moderate COVID-19 treated with the anti-malarial drug did not clear the virus quicker than those receiving standard care. More adverse events were also recorded in patients treated with hydroxychloroquine. Findings from both studies, published in The BMJ journal, add to growing evidence that hydroxychloroquine may not be effective against COVID-19.
[section= May 13, 2020]
Moderna’s investigational mRNA vaccine for COVID-19, called mRNA-1273, was awarded the FDA’s fast-track designation, the first to receive this status, which is intended to speed up the review time for a potential medication. The company anticipates launching a Phase 3 trial testing the vaccine in early summer.
An observational study conducted by the University of Albany and the New York State Department of Health found no benefit to treating COVID-19 patients with hydroxychloroquine. This is at least the third such study to reach this conclusion, according to the FDA. After reviewing the medical records of 1,438 patients from 25 hospitals in the greater New York area, the researchers found that treatment with hydroxychloroquine, azithromycin, or both did not significantly lower the in-hospital death rate. The study was published in the Journal of the American Medical Association.
rolling out a second Phase 3 trial the safety and efficacy of compared with standard care in patients with COVID-19 who develop . Jakafi is a prescription medication for , , and . The trial will be conducted in the U.S. The companies had previously announced a Phase 3 trial called RUXCOVID, which is examining Jakafi’s effectiveness in treating COVID-19-associated cytokine storm. That trial is currently underway.and are
A new Phase 2 trial National Institute of Allergy and Infectious Diseases, follows on the heels of another study that found that remdesivir on its own shortened patients’ recovery time over a placebo.to investigate the effectiveness of with in treating COVID-19. It is expected to enroll up to 1,000 participants at 100 sites worldwide. Enrollment has already begun in the U.S. Remdesivir is an investigational broad-spectrum antiviral being developed by . It is not yet approved anywhere in the world for any indication. Olumiant is an anti-inflammatory by used to treat some patients with . The trial, being sponsored by the
A Phase 2 trial (combo therapy suppressed the virus at day seven. This was five days earlier than in patients who were treated with Kaletra only. The combo was also found to be safe, leading to minor gastrointestinal side effects such as diarrhea and vomiting.) conducted in China tested a combination of three antivirals, (lopinavir-ritonavir), an antiviral, , a treatment, and , a treatment used in . The trial, completed on March 31, that the
The FDA emergency use authorization for a new laboratory test kit to detect SARS-CoV-2. The kit, called can detect the genetic material of the virus in oral and nasal swabs as well as sputum.
[section= May 6, 2020]
The U.S. Food and Drug Administration has granted Gilead Sciences’ remdesivir emergency use authorization for the treatment of COVID-19, the company recently announced. The agency’s decision was based on available data from two global Phase 3 clinical trials.
Top-line results from one of these Phase 3 trials, known as SIMPLE (NCT04292899), showed that a shorter, five-day course of treatment with remdesivir leads to similar improvements in clinical status as a 10-day course of treatment in patients hospitalized with severe COVID-19. The open-label trial is testing the effects of two dosing durations (five days and 10 days) of the experimental antiviral.
The European Medicines Agency also began a rolling review of remdesivir for COVID-19, with the goal of shortening the review time of the treatment from months to weeks.
The FDA granted emergency use authorization to a new antibody test for COVID-19. The test, developed by Roche, is called Elecsys. It is able to determine with 100% sensitivity and 99.8% specificity whether a person has been exposed to SARS-CoV-2 in the past and developed antibodies against the virus.
The first participants have been dosed in a Phase 1/2 trial in the U.S. that is testing four mRNA vaccine candidates being jointly developed by BioNTech and Pfizer against COVID-19. The first part of the trial is a dose escalation stage that is enrolling up to 360 healthy individuals. The BNT162 vaccine program also includes a similar trial in Germany, which completed dosing of its first group last week.
Massachusetts General Hospital is conducting a clinical study to assess the potential efficacy of inhaled nitric oxide to reverse hypoxemia (abnormally low oxygen levels in the blood) in patients with severe COVID-19. Mallinckrodt Pharmaceuticals is providing both funding and INOmax — nitric oxide gas for inhalation — for the study.
Patients are being enrolled in a Phase 2 trial at Beaumont Hospital in Royal Oak, Michigan, to test a combination of naltrexone and ketamine for treating COVID-19. Researchers will assess whether reducing inflammation with the combo therapy may lessen the severity of COVID-19 symptoms.
AstraZeneca and the University of Oxford are collaborating on developing a potential vaccine against COVID-19 to be developed and distributed globally. The potential vaccine, called ChAdOx1 nCoV-19, is being developed by the University of Oxford and will be manufactured and distributed by AstraZeneca.
[section= April 29, 2020]
German regulatory authority Paul-Ehrlich-Institut approved a Phase 1/2 clinical trial for BioNTech and Pfizer‘s BNT162 vaccine program, which is testing four mRNA vaccine candidates to prevent COVID-19. In the first phase of the trial, researchers will test the vaccines in 200 healthy volunteers ages 18 to 55 to determine the optimal dose. The second part will include participants at a higher risk of severe COVID-19.
Asthma medication MN-166 (ibudilast) will be tested in a clinical trial to assess its potential in treating acute respiratory distress syndrome caused by COVID-19. The trial is a collaboration between Yale University and pharmaceutical company MedicNova.
A trial called STOP-COVID19 is expected to start recruiting up to 300 hospitalized patients with COVID-19 in the U.K. in May to test the experimental treatment brensocatib. Insmed, which is developing the treatment for bronchiectasis and other inflammatory diseases, will provide funding and the medication for the trial, which is sponsored by the University of Dundee.
A new trial funded by Amazon and run by Columbia University will assess whether plasma (the liquid portion of the blood devoid of cells) obtained from COVID-19 survivors can be used to prevent SARS-CoV-2 infections or treat COVID-19. The trial aims to recruit 450 people who have been in close contact with COVID-19 patients such as healthcare workers as well as intensive care unit patients.
Astra Zeneca will test the diabetes treatment Farxiga (dapagliflozin) in a trial to assess its potential to decrease the risk of death from serious complications and organ failure in COVID-19 patients. The trial, which is a collaboration with Saint Luke’s Mid America Heart Institute, will enroll 900 participants in the U.S. and European countries that are experiencing high rates of COVID-19 cases.
An experimental treatment by Vivacelle Bio will be made available for compassionate use in COVID-19 patients. The experimental treatment, called VBI-S, is currently being tested in a Phase 2 trial (NCT04257136) people with reduced blood circulation due to sepsis.
Quest Diagnostics started offering an antibody testing service for COVID-19 on blood samples. The antibody test, intended for healthcare providers, can determine whether a person has antibodies in their blood against SARS-CoV-2, meaning they have been exposed to the virus and may have some level of immunity against it.
[section= April 22, 2020]
Biogen, Broad Institute, and Partners HealthCare are launching a consortium to build and share a COVID-19 biobank. The biobank will contain blood samples of Biogen employees willing to participate in the project who contracted and have recovered from COVID-19. People identified as close contacts of those individuals are also eligible to participate regardless of whether they were confirmed to have COVID-19. The biobank will help scientists understand why some people infected with SARS-CoV-2 become seriously ill while others do not even show any symptoms. A better understanding of the biology of the virus and the response the human body has to it will help speed the quest for potential vaccines and treatments.
Alexion is planning a Phase 3 trial testing Ultomiris (ravulizumab-cwvz) for treating severe COVID-19. The global trial will include approximately 270 hospitalized patients who have severe pneumonia or acute respiratory distress syndrome. Ultomiris is FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS).
In the coming weeks, Novartis is planning to start enrollment for its randomized Phase 3 trial testing hydroxychloroquine in hospitalized COVID-19 patients. An estimated 440 patients will be recruited across more than a dozen U.S. sites.
Sinovac has launched a randomized Phase 1 trial in China to test its vaccine candidate against COVID-19. The first group of an estimated total of 144 healthy adults have already been given the first dose of two doses of the experimental vaccine.
The FDA authorized a saliva test for emergency use to diagnose COVID-19. The test was developed by Rutgers University in collaboration with other groups. The test can only be used in a healthcare setting and is not available to purchase for home testing.
LabCorp has received emergency use authorization from the FDA for the first diagnostic test using samples collected from people at home. The at-home kit includes a special cotton swab to collect a sample from the individual’s nose. The sample is then mailed in an insulated package to a LabCorp lab. The products contained in the LabCorp collection kit are the only ones authorized for at-home use at this time.
[section= April 15, 2020]
Biohaven Pharmaceuticals will soon start a Phase 2 clinical trial to test intranasal vazegepant in treating lung complications caused by COVID-19. The trial will run in collaboration with Thomas Jefferson University and other institutions.
The FDA has cleared a Phase 2 trial that will test the safety and efficacy of Hope Biosciences’ adipose-derived mesenchymal stem cells to provide immune support against COVID-19. The trial will enroll an estimated 100 front-line healthcare workers and first responders and will test three doses of cells over 14 weeks.
Vaxil has completed the first preclinical experiment testing its COVID-19 vaccine candidate. According to the results, the vaccine candidate showed a favorable immune response in healthy donor blood cells. The company has now begun the next set of experiments to better understand the immune responses and determine dosing, with additional experiments planned.
Sanofi and GlaxoSmithKline are partnering on developing an adjuvanted COVID-19 vaccine. Sanofi is providing its S-protein COVID-19 antigen, based on a recombinant RNA technology that created an exact match to proteins found on the surface of the virus. GSK will contribute its pandemic adjuvant technology, which is intended to boost the immune response and may lead to a stronger and longer-lasting effect than the vaccine alone. The companies are aiming to launch a Phase 1 trial in the second half of this year.
[section= April 8, 2020]
(high-dose inhaled nitric oxide therapy) can now be tested in patients infected with SARS-CoV02 as part of a Phase 2 clinical trial () that began in 2017 to assess its effects in treating difficult lung infections. and , developers of Thialonax, on April 1 that their joint pilot trial was cleared by the . The trial will now be able to recruit participants infected with SARS-CoV-2 at Vancouver Coastal Health Authority facilities to test the therapy’s safety and effectiveness in treating COVID-19.
The FDA a randomized, double-blind, placebo-controlled Phase 3 trial () to evaluate the safety and efficacy of plus standard of care in hospitalized adults with severe COVID-19 pneumonia. Actemra is an anti-rheumatoid medication by that is also being evaluated in a as a potential treatment for COVID-19.
A Phase 3 trial called RUXCOVID is to evaluate the safety and efficacy of in COVID-19-associated . The medication was developed by and is sold under the brand-name Jakafi for , , and . Two more trials will test ruxolitinib in treating severe acute respiratory syndrome (SARS) caused by COVID-19 () and COVID-19 pneumonia (). The trials will take place in Mexico and in Canada respectively, but are not yet recruiting patients.
Researchers are working on a new RNA-based immunotherapy to treat COVID-19. The potential treatment would be inhaled by patients and produce therapeutic antibodies in the lungs. and to start trials testing the potential treatment by the end of the year.
[section= April 1, 2020]
Several tests for diagnosing COVID-19 have now been granted emergency use authorization (EUA) from the FDA. As of March 31, the Advanced Medical Technology Association estimated that 17 tests had received EUAs, with more in the works. The same day, Bodysphere announced it was rolling out a test that returned results within two minutes, saying it was granted an EUA, but the FDA later refuted that claim. The test at this point has not received any FDA authorization.
The FDA issued a warning last week that it has not authorized any test for people to use at home for COVID-19 and that people should be aware of such fraudulent tests. It also provided a list of fraudulent COVID-19 products including those that claim to prevent or treat the disease.
The agency also announced the creation of an emergency program called the Coronavirus Treatment Acceleration Program to assist in the development of treatments for COVID-19. According to the FDA, as of March 31, it is reviewing 10 therapies already in trials and 15 others in preclinical stages.
Sandoz’s malaria treatment hydroxychloroquine sulfate and Bayer Pharmaceuticals’ chloroquine phosphate have been granted an EUA by the FDA for the treatment of COVID-19. Both companies have donated supplies of the medications to the U.S. Department of Health and Human Services for use. Although clinical trials are needed to prove their efficacy in treating COVID-19, these therapies have shown some benefit in the lab and clinic, according to anecdotal evidence.
Among the trials recently launched for COVID-19 are a global Phase 2/3 trial (NCT04315298) testing rheumatoid arthritis treatment Kevzara (sarilumab) and a U.K.-based Phase 2 trial testing antiviral SNG001, an inhaled formulation of interferon-beta-1a. The first patients have already been treated in both trials. Another Phase 2/3 trial (NCT04315298) testing Kevzara is recruiting an estimated 400 participants in the U.S.
Johnson & Johnson announced plans to start a Phase 1 trial by September to test its vaccine candidate Ad26 SARS-CoV-2 against COVID-19. If the trial is successful, the first batch of the vaccine could be available in early 2021 for emergency use, according to the company.
[section= March 27, 2020]
The CDC has developed a diagnostic panel for use by CDC-qualified laboratories in the U.S. and made available under an emergency use authorization (EUA) from the FDA
Other new tests include Roche Diagnostics’ cobas SARS-CoV-2 test, also granted an EUA, and the U.S. Department of Health and Human Services is funding the development of two other diagnostic tests that can detect the presence of SARS-CoV-2 within one hour.
The National Institute of Allergy and Infectious Diseases is sponsoring a randomized, controlled Phase 2 trial in the U.S. to evaluate the safety and efficacy of the broad-spectrum anti-viral treatment remdesivir by Gilead Sciences to treat the disease. Gilead has also launched two global Phase 3 trials to evaluate remdesivir’s safety and efficacy in adults with COVID-19.
Other treatments being investigated for COVID-19 include a novel mRNA-1273 nanoparticle-encapsulated vaccine (NCT04283461), thalidomide (NCT04273581), sildenafil (NCT04304313), eculizumab (NCT04288713), recombinant human interferon-alpha 1 beta (NCT04293887), bevacizumab (NCT04305106), and antibodies from cured patients (NCT04264858), among others.
Researchers are also looking at new synthetic biology approaches by using self-assembling nanoparticles coated with viral antigens that can precisely target SARS-CoV-2. This approach can potentially overcome some of the limitations of conventional vaccines such as short shelf-life and viral evolution.
What is COVID-19?
COVID-19, short for coronavirus disease 2019, is an infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is a newly identified pathogen that has not previously been seen in humans and is highly contagious. Though it belongs to the same category of viruses as SARS coronavirus (SARS-CoV) and influenza viruses, SARS-CoV-2 is a different strain with its own characteristics.
How does COVID-19 spread?
Because COVID-19 is a new virus, nobody has prior immunity to it, meaning the entire human population is prone to infection.
It primarily spreads via respiratory droplets when people cough or sneeze. Scientists have yet to understand how easily and sustainably the disease can spread among people. Based on available evidence, researchers do not think airborne spread is a major transmission route.
Individuals over age 60 are at the highest risk of developing a severe case of COVID-19, while children do not seem to be at a higher risk than adults.
There are currently no reports about how susceptible pregnant women may be to COVID-19 or about transmission of the virus through breast milk.
What are the symptoms of COVID-19?
Common symptoms of COVID-19 begin two to 14 days after exposure. They include fever, tiredness, and dry cough. Other symptoms include sputum production, shortness of breath, sore throat, headache, myalgia (muscle pain) or arthralgia (joint pain), chills, vomiting, and nasal congestion. Less frequent symptoms include diarrhea, hemoptysis (coughing up blood from the respiratory tract), and conjunctival congestion.
Most of these symptoms are usually mild, and about 80% of people who get the virus will typically recover without needing any special treatment. However, about 1 in 6 patients become seriously ill and develop breathing difficulties.
What general preventive measures should people take?
The following simple preventive measures can help minimize the spread of COVID-19:
- Wash your hands often with soap, lathering both the front and the back of the hands and fingers for at least 15 to 20 seconds. If soap is not available, use a hand sanitizer that contains at least 60% alcohol. The European Centre for Disease Prevention and Control produced a poster detailing effective handwashing.
- Avoid close contact with someone who is ill. (Maintain a distance of at least 6 feet, or 1.8 meters).
- Stay at home if you are sick.
- Use a tissue to cover your mouth and nose if you cough or sneeze and dispose of it properly afterward.
- Disinfect surfaces and objects you touch frequently.
- Avoid touching your eyes, nose, and mouth with unwashed hands.
Are there any specific recommendations for people with mitochondrial disease?
There is currently no information about how COVID-19 may affect individuals with mitochondrial disease. However, it is possible they are at a higher risk of complications than the general public if they get a COVID-19 infection.
Patients and their caregivers should, therefore, take extra precautions to minimize the risk of coming in contact with the virus. In addition to the general preventive measures listed above, patients and caregivers should:
- Stock up on necessary medications and supplies that can last for a few weeks.
- Avoid crowds and non-essential travel.
- Stay at home as much as possible.
Advice for family members and caregivers
Family members and caregivers of people with mitochondrial disease should take appropriate precautions and take extra care to avoid bringing COVID-19 home. They should constantly monitor patients and stock medicines and other necessary supplies that can last for several weeks. Storing extra non-perishable food can help minimize trips to the grocery store.
People who show symptoms of COVID-19 should avoid visiting their family members in nursing homes or other places until the self-isolation period is complete.
What should sick individuals do?
If symptoms are present and a COVID-19 diagnosis is confirmed, patients should follow these steps to prevent the spread of the infection:
- Stay at home, preferably in a separate room not shared with others, and isolate themselves, with the exception of getting medical care.
- Avoid public areas and public transport.
- Limit contact with pets and animals.
- Avoid sharing personal items.
- Cover coughs and sneezes with tissues and dispose of them properly.
- Sanitize hands regularly.
- Disinfect surfaces such as phones, keyboards, toilets, and tables.
People should call ahead before visiting the hospital for an appointment. This way, the hospital can take necessary steps to prevent the spread of the infection.
What tests are available?
Many tests for the detection of COVID-19 have been made available under the FDA’s emergency use authorization, including rapid tests that are being developed to detect the presence of the virus within minutes.
Is there a treatment?
There are currently no vaccines available for human coronaviruses including COVID-19. This makes the prevention and containment of the virus very important.
Are there new treatments in the pipeline?
Several clinical trials have been launched or are being planned to test a variety of potential treatments and vaccines for COVID-19. A complete list of all ongoing clinical trials pertaining to the virus is available here.
Mitochondrial Disease News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.