July 27 2020
Moderna Begins Phase 3 TrialModerna Vaccine Begins Phase 3 Trial, Receives $472M From Trump Administration In beginning the first phase 3 clinical trial to examine a vaccine candidate against COVID-19, Moderna announces that the Trump administration increased funding by $472 million to expand the trial to 30,000 US participants. The move now brings the total investment made by the Biomedical Advanced Research and Development Authority to $955 million.
July 29 2020
FDA Grants EUA for Rapid Antibody Test
FDA Grants Truvian EUA for Rapid Antibody Test
FDA grants Truvian Sciences an EUA for its Easy Check COVID-19 IgM/IgG antibody test after it was shown to exceed EUA requirements, including a sensitivity rate of 98.44% and a specificity of 98.9%. The announcement follows the FDA’s increased oversight of antibody tests on May 5, requiring them to meet standards of other molecular tests.
August 6 2020
Prophylactic and therapeutic use of Ivermectin
Uttar Pradesh government, first to have introduced a large-scale “prophylactic and therapeutic” use of Ivermectin. Health Department introduced Ivermectin as prophylaxis for close contacts of Covid patients, August 6, 2020. None of them ended up developing Covid-19 Despite being in daily contact.
August 11 2020
Deal With Moderna
Trump Administration Reaches Deal With Moderna
Despite still waiting on final data, the Trump administration reportedly agrees to pay $1.5 billion to Moderna for 100 million doses of its vaccine candidate, mRNA-1273, or an average per-dose price of $15. The vaccine, however, is still under investigation in the joint phase 3 COVE trial Moderna is conducting with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
August 15 2020
Ivermectin recovery time, 70.0% lower
August 15 – Ivermectin: recovery time, 70.0% lower, relative time 0.30, p < 0.001, treatment 28, control 7.
risk of viral+ at day 10, 97.2% lower, RR 0.03, p < 0.001, treatment 0 of 28 (0.0%), control 7 of 7 (100.0%), continuity correction due to zero event.
Espitia-Hernandez et al., 8/15/2020, retrospective, Mexico, North America, peer-reviewed, mean age 45.1, 5 authors, dosage 6mg days 1-2, 8-9, this trial uses multiple treatments in the treatment arm (combined with azithromycin and cholecalciferol) – results of individual treatments may vary.
August 20 2020
HCQ is protective to the heart, not harmful
Hydroxychloroquine is protective to the heart, not harmful: A systematic review
Review concluding that HCQ/AZ does not cause Torsade de Pointes or related deaths, HCQ decreases cardiac events, and HCQ should not be restricted in use for COVID-19 patients because of fear of cardiac mortality.
Prodromos et al., 8/20/2020, peer-reviewed, 3 authors.
August 21 2020
Protesting the UCP’s school re-entry plan
Teachers, parents and students across the province of Alberta hold rallies to protest the UCP’s school re-entry plan, which does not include funding to reduce class sizes. Concerns also grow around topics such as ventilation, sanitation and staffing.
August 24 2020
Remdesivir’s Clinical Benefits Questioned
A global, multicenter study finds that the antiviral drug remdesivir had little effect on patients hospitalized with COVID-19. The findings, published in JAMA, indicate there were no significant differences in duration of supplemental oxygen or hospitalization between the intervention group given remdesivir and the control group given standard care.
August 25 2020
CDC quietly changes its guidance
The CDC quietly changes its guidance on who should get tested for COVID-19, saying that individuals who are asymptomatic, but have been exposed, do not need testing. After it is revealed the decision had bypassed CDC’s usual scientific review process and without internal review, the changes are reversed.
August 26 2020
A portable rapid test EUA
A portable rapid COVID-19 test that can deliver results in under 15 minutes was cleared by the FDA under an EUA. The test is aimed at places like workplaces and schools.
August 28 2020
Ivermectin lowers risk of symptomatic case by 91.3%
Ivermectin: risk of symptomatic case, 91.3% lower, RR 0.09, p < 0.001, treatment 15 of 203 (7.4%), control 59 of 101 (58.4%), adjusted, multivariate.
risk of COVID-19 severe case, 92.9% lower, RR 0.07, p = 0.002, treatment 1 of 203 (0.5%), control 7 of 101 (6.9%), unadjusted.
Shouman et al., 8/28/2020, Randomized Controlled Trial, Egypt, Africa, peer-reviewed, 8 authors, dosage 18mg days 1, 3, dose varies depending on weight – 40-60kg: 15mg, 60-80kg: 18mg, >80kg: 24mg.
August 28 2020
First reported reinfection in the US
A 25-year-old man from Nevada became reinfected with COVID-19 in late May after recovering from a mild case in April, reports say. It marks the first reported case of reinfection in the United States; the second occurrence resulted in a much more severe case, requiring hospitalization and oxygen. A full study of the case is published in Lancet Infectious Disease Journal in October.
September 1 2020
Do not warrant closing classrooms?
Jason Kenney (Alberta) says his government has accepted that COVID-19 infections in schools are inevitable and don’t warrant closing down all classrooms: “It’s time to go back to some kind of normal.”
September 8 2020
AstraZeneca Halts Phase 3 Vaccine Trial
The phase 3 trial for AstraZeneca’s potential COVID-19 vaccine is halted for a safety data review following an unknown adverse reaction in a patient. The patient was part of the United Kingdom arm of the trial. At the time, the nature of the adverse reaction was not known, but the company did say that the participant was expected to recover. AstraZeneca says the hold was initiated as “a routine action.”
September 14 2020
Pfizer, BioNTech Expand Phase 3 Trial
After initially aiming to recruit 30,000 participants, Pfizer and BioNTech announce they will expand the phase 3 trial of their COVID-19 vaccine by 50% to 44,000. The goal of expanding the trial is to increase data on safety and efficacy and promote a more diverse population, including adolescents as young as 16 years and patients with HIV, hepatitis C, or hepatitis B. The Pfizer/BioNTech vaccine is provided as 2 shots given 3 weeks apart, but the vaccine must be kept at a temperature of –70 degrees Celsius (–94 degrees Fahrenheit), which may make distribution a challenge.
September 15 2020
Ivermectin lowers moderate/severe patients by 85.4%
Ivermectin:moderate/severe patients, 85.4% lower, RR 0.15, p = 0.08, treatment 1 of 32 (3.1%), control 3 of 14 (21.4%), the only treatment death was a patient already in the ICU before treatment.
Carvallo et al., 9/15/2020, prospective, Argentina, South America, peer-reviewed, mean age 55.7, 3 authors, dosage 36mg days 1, 8, dose varied depending on patient condition – mild 24mg, moderate 36mg, severe 48mg, this trial uses multiple treatments in the treatment arm (combined with dexamethasone, enoxaparin, and aspirin) – results of individual treatments may vary.
September 21 2020
Johnson & Johnson Begins Phase 3 Vaccine Trial
Johnson & Johnson announces that it began a large phase 3 clinical trial of its COVID-19 vaccine candidate. This vaccine does not need to be frozen and may require 1 administration instead of 2. The trial is expected to test the vaccine in 60,000 participants, making it the largest phase 3 trial of all vaccines currently being tested.
September 23 2020
A New, More Contagious Strain
A study conducted at Houston Methodist Hospital finds a more contagious strain of COVID-19 in a large portion of recent patient samples. Investigators analyzed samples from the earliest phase of the pandemic and a more recent infection wave, finding that nearly all strains from the more recent phase had a mutation that allows the virus to bind and infect more cells.
September 29 2020
Monoclonal Antibody Treatment
Regeneron releases study results from its ongoing phase 1/2/3 trial showing that its proposed monoclonal antibody treatment for COVID-19, REGN-COV2, was linked to quicker recovery, reduced viral load, and the need for fewer medical visits. REGN-COV2 is a mixture of 2 monoclonal antibodies (REGN10933 and REGN 10987).
October 2 2020
Chloroquine + azithromycin
Chloroquine + azithromycin risk of death, 27.6% lower, RR 0.72, p = 0.17, treatment 69 of 630 (11.0%), control 28 of 96 (29.2%), adjusted, OR converted to RR.
>risk of no improvement, 25.8% lower, RR 0.74, p = 0.13, adjusted, OR converted to RR.
Nachega et al., 10/2/2020, retrospective, database analysis, DR Congo, Africa, peer-reviewed, median age 46.0, 25 authors.