Covid-19 Living Data

Trial NCT04518410
Publication ACTIV-2 - Jilg N, Top Antivir Med (2022) (unpublished results)

Funding: Not reported/unclear
Conflict of interest: *

Methods
	RCT Blinding: triple blinding
	Location : Multicenter / USA Follow-up duration (days): 28
Inclusion criteria	Hospitalized adults with mild-moderate COVID-19
Exclusion criteria	NR
Interventions
	Treatment Camostat Mesilate 200 mg orally every 6 hours for 7 days
	Control Placebo
Participants
	Randomized NR Analyzed 215 participants Placebo=107 Camostat Mesilate=108
	Characteristics of participants N= 215 Mean age : NR 0 males Severity : Mild: n= / Asymptomatic: n= Number of vaccinated participants: NR
Primary outcome
	In the register 1) COVID-19 symptom duration (Phase 2) [ Time Frame: Up to Day 28 ] Duration defined as the number of days from start of investigational agent to the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent, AND any symptoms scored as mile or absent at study entry (pre-treatment) are scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3) 2) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 3 ] Measured as quantification (4) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 14 ] Measured as quantification (5) Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2) [ Time Frame: Thru Day 28 ] Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3) [ Time Frame: Thru Day 28 ] Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
	In the report Safety and efficacy of camostat to reduce the duration of COVID-19 symptoms and increase the proportion of participants with SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) from nasopharyngeal (NP) swabs on days 3, 7, and 14
Documents available	Protocol NR Statistical plan NR 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	*
General comment	The published abstract and study registry were used in data extraction. No review specific outcomes were extractable. This study is part of the the ACTIV-2 platform trial.