A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19 (Trial H1: Aviptadil)
Phase: PHASE3
Conditions: Covid19
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Overview of Study Documents 
 
A Multicenter, Adaptive, Randomized, 
Blinded Controlled Trial of the Safety and 
Efficacy of Investigational Therapeutics for 
Hospitalized Patients with Acute 
Respiratory Distress Syndrome Associated 
with COVID-19 
 
 
 
05 August 2025 
 
NCT06729606 
(Master protocol: NCT04843761) 
 
 
 

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 ( TESICO ) trial.  
Overview of Trial Documents  
Master protocol:  
 
NCT04843761 
Aviptadil Substudy (H1):  
NCT06729606 
Remdesivir Substudy (H2):  NCT06729593 
 
Document 
Document Date 
Description 
Study Protocol: Master 
 
March 8, 2022 
The master protocol document for 
TESICO/ACTIV-3b.    
 
This document should be used together with 
the agent speciﬁc appendices (H1 and H2) to 
understand the data collection for the 
Aviptadil and Remdesvir substudies.   
Study Protocol: 
Aviptadil (H1) 
 
March 8, 2022 
 
Appendix H1 to the TESICO master protocol 
document.  Provides additional agent-speciﬁc 
information for the Aviptadil component of 
the trial.   
Study Protocol: 
Remdesivir (H2) 
 
April 1, 2021 
 
Appendix H2 to the TESICO master protocol 
document.  Provides additional agent-speciﬁc 
information for the Remdesivir component of 
the trial and a description of the 4 
randomization strata used for enrollment into 
both agents. 
Statistical Analysis 
Plan: Main 
 
August 5, 2021 
 
This document applies for both the Aviptadil 
and Remdesivir substudies. 
Statistical Analysis 
Plan: Addendum 
 
May 1, 2022 
 
This document applies to the Aviptadil 
substudy. 
Informed Consent 
March 8, 2022 
This document applies for both the Aviptadil 
and Remdesivir substudies.