Covid-19 Living Data

Trial NCT04709835
Publication NCT04709835, Unpublished (2022) (results posted on registry)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Canada, Greece, Ireland, Latvia, Spain, UK Follow-up duration (days): 33
Inclusion criteria	Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test)at screening Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days prior to randomization
Exclusion criteria	Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against SARS CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening Requirement, in the opinion of the investigator, for any of the prohibited medications during the study Use of hydroxychloroquine or amiodarone within 3 months of screening Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of AT-527. Women of childbearing potential must have a negative urine pregnancy test result at screening Abnormal laboratory test results at screening Clinically significant abnormal ECG, as determined by the Investigator, at screening Planned procedure or surgery during the study Known allergy or hypersensitivity to study drug or drug product excipients Substance abuse, as determined by the investigator, within 12 months prior to screening Poor peripheral venous access Malabsorption syndrome or other condition that would interfere with enteral absorption Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion History of anaphylaxis Any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Interventions
	Treatment AT-527 550 mg 550 mg orally twice a day for 5 days AT-527 1100 mg 1100 mg orally twice a day for 5 days
	Control Placebo
Participants
	Randomized NR Analyzed 100 participants AT-527 550 mg=30 AT-527 1100 mg=30 Placebo=40
	Characteristics of participants N= 100 Mean age : NR 46 males Severity : Mild: n= */ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 1. Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 550 mg and Matched Placebo [ Time Frame: Baseline, Day 3, Day 5, Day 7 ] SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement. 2. Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA for AT-527 1100 mg and Pooled Placebo [ Time Frame: Baseline, Day 3, Day 5, Day 7 ] SARS-CoV-2 virus RNA was measured by reverse-transcription polymerase chain reaction (RT-PCR) from NP swabs. The change from baseline was estimated from an ANCOVA model with baseline viral load as a covariate. Reported here is the adjusted mean change from baseline. A negative change from baseline indicates an improvement.
	In the report NR
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	This is an unpublished trial whose results have been reported in ClinicalTrials.gov. The trial registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. The trial was registered prospectively and no important changes were made to primary or secondary outcomes after recruitment start.