Clinical trials for COVID-19 drugs & when to expect results

There are hundreds of clinical trials in the U.S. and abroad testing potential treatments for COVID-19. 

Clinicaltrials.gov lists 40 active ones in the U.S. and more than 300 internationally.

Here's a breakdown of the key clinical trials and when to expect results, from Politico:

  1. Hydroxychloroquine — Hydroxychloroquine and chloroquine are the most talked-about drugs being tested against COVID-19, as President Donald Trump has called them "game changers" in the country's pandemic response during his daily news briefings. The drugs are essentially the same, but hydroxychloroquine is a safer, more commonly used version of chloroquine. Many drugmakers make their own versions of hydroxychloroquine, which was originally approved to treat malaria but is now commonly used to treat autoimmune diseases, including lupus and rheumatoid arthritis.

    Clinical trials: There are 148 clinical trials involving hydroxychloroquine being conducted in the U.S. and abroad, according to Clinicaltrials.gov. The National Institutes of Health is assisting in a phase 3 trial for 510 adults hospitalized with COVID-19. The University of Minnesota is also in a phase 3 trial involving 3,000 participants. Hospitals in New Jersey, Utah, and Pennsylvania are also conducting hydroxychloroquine trials, Politico reported.

    When to expect results: A spokesperson told Politico results from the NIH trial will come in "a couple of months." Results from the other trials depend on how quickly researchers can enroll participants.

  2. Remdesivir (Gilead) — The furthest along in the development process of any drug being tested to treat COVID-19, remdesivir is an intravenous drug that works by targeting the system coronaviruses use to replicate themselves. It hasn't been approved in the U.S., but it was tested to treat Ebola, so researchers already have some information about how humans respond to it. Researchers are hoping it can reduce the intensity and duration of COVID-19.

    Clinical trials: Gilead is running two trials in the U.S., Asia and Europe, according to Politico. One is testing 6,000 severely ill COVID-19 patients, while the other is testing 600 moderately ill patients. The National Institute of Allergy and Infectious Diseases has also started the first randomized, controlled trial of the drug with 1,060 patients worldwide.

    When to expect results: Gilead released the first results from its phase 3 clinical trial April 29, saying remdesivir proved effective against COVID-19. Data from Gilead's second clinical trial testing moderately ill patients is expected in late May. Data from the NIAID trial is also expected in late May, according to Politico

  3. Avigan (Fujifilm) — Avigan is a flu drug that has been tested in China, where it helped patients recover seven days faster than patients on a different antiviral drug. The drug is approved in Japan but not in the U.S.

    Clinical trials: Fujifilm launched a phase 3 clinical trial in Japan on March 31. It also started a phase 2 trial in April for about 50 patients at three Boston area hospitals, Politico reported.

    When to expect results: Fujifilm hasn't released details on how long the trials will take.

  4. Actemra (Roche) — Actemra is classified as an IL-6 inhibitor and may work by stopping a biological mechanism that causes overactive inflammatory responses in patients' lungs.

    Clinical trials: A clinical trial in France showed improved outcomes for Actemra in COVID-19 patients who had moderate or severe pneumonia, Politico reported. Roche is also sponsoring a phase 3 trial of 330 hospitalized COVID-19 patients with severe pneumonia in the U.S. and Europe.

    When to expect results: A Roche spokesperson told Politico the results could be released in early summer. 

  5. Olumiant (Eli Lilly) — Olumiant is a rheumatoid arthritis drug that was identified as a potential coronavirus treatment by an artificial intelligence system in the U.K., according to Politico. Though the drug has a warning label saying it can make infections worse, it will be tested on patients with COVID-19 infections because it suppresses the immune system, which suggests it could suppress an immune system overreaction seen in some severely ill COVID-19 patients.

    Clinical trials: Eli Lilly is working with NIAID to study Olumiant as part of a placebo-controlled trial in the U.S., Europe and Asia, according to Politico.

    When to expect results: Eli Lilly told Politico to expect data on Olumiant in the next two months. 

  6. Calquence (AstraZeneca) — Calquence is designed to treat lymphoma, but may reduce the inflammation caused by COVID-19, which can trigger an extreme immune reaction that can be fatal.

    Clinical trials: AstraZeneca said it will conduct a randomized, controlled trial of Calquence in COVID-19 patients, according to Politico.

    When to expect results: The drugmaker hasn't said when it plans to release data. 

Other potential COVID-19 treatments undergoing clinical trials:

  1. Convalescent plasma — Convalescent plasma is antibody-rich blood products taken from blood donated by people who have recovered from COVID-19. The theory behind the treatment is that the antibodies from recovered COVID-19 patients can help sick COVID-19 patients recover.

    Clinical trials: Hackensack (N.J.) University Medical Center is conducting a phase 2 study with 55 participants to test convalescent plasma as a treatment for COVID-19, Politico reported. Several hospitals in the Netherlands and Spain are also conducting clinical trials. The FDA is also coordinating a study that will be conducted by NIAID.

    When to expect results: There aren't any specific timelines on when clinical trial results will be released.

  2. Steroids — Hospitals in China used corticosteroids to reduce inflammation in COVID-19 patients, but it's not clear if the strategy has been effective, according to the CDC. The CDC has warned against using steroids to treat COVID-19 because patients with MERS or the flu who were given steroids were more likely to die than those who didn't receive the drugs, according to Politico.

    Clinical trials: A clinical trial in the U.K. began in March to test a low dose of the steroid dexamethasone, Politico reported. Scientists in South Korea are also recruiting people to test whether the steroid ciclesonide can help COVID-19 patients with mild symptoms.

    When to expect results: There aren't any specific timelines on when clinical trial results will be released. 

More articles on pharmacy:
Top 15 specialty pharmacies by revenue
CVS to offer self-swab COVID-19 tests at 1,000 pharmacies
Walgreens to add COVID-19 testing sites in 49 states

© Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 

Featured Webinars

Featured Whitepapers