Coronavirus COVID-19 Update for April 16, 2022

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Clinical Reports

Children and COVID-19: State Date Report
A joint report from the American Academy of Pediatrics and the Children’s Hospital Association. Summary of publicly reported data from 49 states, NYC, DC, PR, and GU Version: 4/16/22. The numbers in this report represent cumulative counts since states began reporting. The data are based on how public agencies collect, categorize and post information. All data reported by state/local health departments are preliminary and subject to change and reporting may change over time. Notably, in the summer of 2021 and winter of 2022, some states have revised cases counts previously reported, begun reporting less frequently, or dropped metrics previously reported. For example, due to several changes on their dashboards and the data currently available, AL, TX, HI, DC and MS data in this report are not current (cumulative data through 7/29/21, 8/26/21, 1/13/22, 3/3/22, and 3/10/22 respectively). Readers should consider these factors. States may have additional information on their web sites.
Symptom prevalence, duration, and risk of hospital admission in individuals infected with SARS-CoV-2 during periods of omicron and delta variant dominance: a prospective observational study from the ZOE COVID Study
In this study, researchers collected data from participants who self-reported test results and symptoms in the ZOE COVID app. Eligible participants were aged 16-99, received two doses of an SARS-CoV-2 vaccine, were symptomatic, and logged a positive PCR or lateral flow result for SARS-CoV-2 during the study period. This was based in the United Kingdom. What the study looked at was the outcome of developing a given symptom or hospital admission within 7 days before or after the positive test in participants infected during omicron prevalence vs those infected during delta prevalence. What the study found was that sore throat was reported 70% of the time with Omicron but 60% with Delta. When it came to loss of smell, it went from 50% during delta to 20% with omicron. Differences in terms of symptoms and symptom duration are statistically significant at a population level but this does not mean clinically this is different at an individual level. It was also reported there was a shorter duration of symptoms, but their data suggested this may be a reflection of vaccination status.
Infectious viral load in unvaccinated and vaccinated individuals infected with ancestral, Delta or Omicron SARS-CoV-2
In this study the authors quantified infectious VL in SARS-CoV-2 infected individuals during the first 5 symptomatic days using an in vitro culture assay in unvaccinated or vaccinated individuals infected with pre-variant of concern (pre-VOC) SARS-CoV-2, Delta, or Omicron. They found that unvaccinated individuals infected with pre-VOC SARS-CoV-2 had lower infectious VL compared to Delta-infected unvaccinated individuals. For Omicron, reduced infectious VL was only observed in boosted but not in fully vaccinated individuals compared to unvaccinated subjects.

Antiviral Therapeutics and Vaccines

Myopericarditis following COVID-19 vaccination and non-COVID-19 vaccination: a systematic review and meta-analysis
Researchers reported that the overall incidence of myopericarditis from 22 studies (405,272,721 vaccine doses) was 33·3 cases per million vaccine doses, and did not differ significantly between people who received COVID-19 vaccines (395,361,933 doses), and those who received non-COVID-19 vaccines (9,910,788 doses). Compared with COVID-19 vaccination, the incidence of myopericarditis was significantly higher following smallpox vaccinations, but was not significantly different after influenza vaccinations or in studies reporting on various other non-smallpox vaccinations.
Fluvoxamine for Outpatient Management of COVID-19 to Prevent Hospitalization A Systematic Review and Meta-analysis
The study authors looked at the 3 randomized clinical trials that together included 2,196 participants. They suggested that the RRs for hospitalization was somewhere between 0.73-0.78 with a 95% confidence interval of (95% CI, 0.58-1.08) They suggested that there was a moderate probability that fluvoxamine given early could reduce progression to hospitalization by about 20-25%. The three trials they included were the STOP COVID 1 trial [N = 152], STOP COVID 2 trial [N = 547] stopped for futility but still included here for analysis, and TOGETHER trial [N = 1497]. The STOP COVID 2 trial was stopped for futility in May 2021 after an interim analysis found that the low event rate seen in the trial was associated with a less than 10% conditional probability of demonstrating efficacy within an attainable sample size based on recruitment rate. . Fluvoxamine might be of limited benefit reducing progression to hospitalization by about 20-25%. This is however not in the same range as the 85-90% reduction that is seen with Paxlovid, Monoclonal Antibodies or early IV Remdesivir.
Veru’s Novel COVID-19 Drug Candidate Reduces Deaths by 55% in Hospitalized Patients in Interim Analysis of Phase 3 Study; Independent Data Monitoring Committee Halts Study Early for Overwhelming Efficacy
This trial was a Phase 3 double-blind, randomized, placebo-controlled trial evaluating oral, once-a-day dosing of sabizabulin 9 mg versus placebo in hospitalized moderate to severe COVID-19 patients (≥WHO 4) who were at high risk for ARDS and death. Patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo. The trial was conducted inthe United States, Brazil, Colombia, Argentina, Mexico, and Bulgaria. COVID-19 infections treated in the study included the Delta and Omicron variants. A planned interim analysis was conducted in the first 150 patients randomized into the study. The primary efficacy endpoint was the proportion of patients that died by Day 60. Sabizabulin treatment resulted in a 55% relative reduction in deaths (p=0.0029) in the intent to treat population. Placebo group (n=52) had a 45% mortality rate compared to the sabizabulin-treated group (n=98) which had a 20% mortality rate. Sabizabulin treatment was well tolerated in this patient population with no clinically relevant safety observations in the sabizabulin treated group compared to placebo.

Diagnostics

Comparison of Rapid Antigen Tests′ Performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) Variants of SARS-CoV-2: Secondary Analysis from a Serial Home Self-Testing Study
This study looked at 5,506 individuals that met the eligibility criteria for this study. They looked at the percent of participants that had a positive RDT within 48 hours of a positive PCR and found that for Delta this was 79.3% and for Omicron this was 89.5%. There was no suggestion that RDTs were inferior for detection of Omicron.

Epidemiology

SARS-CoV-2 infection in Africa: A systematic review and meta-analysis of standardised seroprevalence studies, from January 2020 to December 2021
This is a meta-analysis of population-based seroprevalence studies to estimate SARS-CoV-2 seroprevalence in Africa. They identified 54 full texts or early results, reporting 151 distinct seroprevalence studies in Africa. Most of these (63%) were low/moderate risk of bias studies of SARS-CoV-2. They reported that seroprevalence rose from 3.0% [95% CI: 1.0-9.2%] in Q2 2020 to 65.1% [95% CI: 56.3-73.0%] in Q3 2021. They found that Seroprevalence was highly heterogeneous both within countries - urban vs. rural (lower seroprevalence for rural geographic areas), children vs. adults (children aged 0-9 years had the lowest seroprevalence) - and between countries and African sub-regions (Middle, Western and Eastern Africa associated with higher seroprevalence). The high seroprevalence within Africa suggests greater population exposure to SARS-CoV-2 than indicated by surveillance data.