Moderna’s closely watched early-stage human trial for a coronavirus vaccine produced Covid-19 antibodies in all 45 participants, the biotech company announced Monday. Each participant was assigned to receive a 25 microgram, 100 mcg or 250 mcg dose, with 15 people in each dose group. Study participants received two doses of the potential vaccine via intramuscular injection.
The goal of phase 1 trials is to evaluate the safety of a new drug in a small group of participants, not effectiveness. Phase 2 trials study whether a drug works. The phase 1 trial involved 45 people. Results on eight of those participants revealed they developed neutralizing antibodies — which are believed to be key in providing protection from the virus — at levels seen in patients who’ve recovered from COVID-19.
Moderna said those who received the two lower doses developed COVID-19 antibodies about two weeks after the second dose. Final information on the 250 microgram dosing was not available. The only side effect, the company reported, was redness around the area where people got the shot. Moderna, which has partnered with the National Institute of Allergy and Infectious Diseases in the trials, is pushing forward with a larger phase 2 study. That phase will also look at the effectiveness of a 50 microgram dose.
Results From Randomized Clinical Trial Do Not Support Hydroxychloroquine for COVID-19
The anti-inflammatory drug hydroxychloroquine does not significantly reduce admission to intensive care or death in patients hospitalized with pneumonia due to covid-19, finds a study from France published by The BMJ on May 14, 2020.A randomized clinical trial from China also published on May 14, 2020, shows that hospitalized patients with mild to moderate persistent covid-19 who received hydroxychloroquine did not clear the virus more quickly than those receiving standard care. Adverse events were higher in those who received hydroxychloroquine.
Taken together, the results do not support routine use of hydroxychloroquine for patients with covid-19.Hydroxychloroquine can reduce inflammation, pain, and swelling, and is widely used to treat rheumatic diseases. It is also used as an anti-malarial drug. Lab tests showed promising results, but accumulating trial and observational evidence has called into question whether there are any meaningful clinical benefits for patients with COVID-19.