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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

NCTNCT06729606 (opens ClinicalTrials.gov in a new tab)Other id015/ACTIV-3b/H1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
471 participants (actual)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · Nih
Design
Randomized · Triple masking
Countries
1 country

United States

Start
20 Apr 2021
Primary completion
22 Aug 2022
Completion
20 Nov 2022
First posted
11 Dec 2024
Last update posted
9 Oct 2025
Conditions
Covid19

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 3

    Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

    NCT06729606

    20 Apr 2021 to 20 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study looks at the safety and effectiveness of Aviptadil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.

Interventions

  • AviptadilBiological
  • Aviptadil PlaceboBiological
  • CorticosteroidDrug

Arms2

  • Experimental

    Aviptadil + SOC

  • Placebo comparator

    Placebo + SOC

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90

    Time frame · Status on Day 90

    Registry description

    The primary outcome was a 6-category ordinal outcome defining the participant's status at Day 90: (1) at home (defined as the type of residence before hospitalization) and off oxygen (recovered) for at least 77 days, (2) at home and off oxygen for 49-76 days, (3) at home and off oxygen for 1-48 days, (4) not hospitalized but either on supplemental oxygen or not at home, (5) hospitalized or in hospice care, or (6) dead.

Secondary outcomes(4)

  1. Number of Participants Who Died Through Day 90

    Time frame · Through Day 90

  2. Number of Participants With a Safety Outcome Through Day 5

    Time frame · Through Day 5

    Registry description

    Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 5

  3. Number of Participants With a Safety Outcome Through Day 28

    Time frame · Through Day 28

    Registry description

    Composite safety outcome of a serious adverse event, Grade 3/4 adverse event, organ failure/serious infection, or death through Day 28

  4. Number of Participants Who Died Through Day 180

    Time frame · Through Day 180

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Status on Day 90

Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90

GroupValue (Participants)
Aviptadil + SOC36
Placebo + SOC31
Secondary and other outcome results(4)
Secondary outcomeCount of participants· Through Day 90

Number of Participants Who Died Through Day 90

GroupValue (Participants)
Aviptadil + SOC86
Placebo + SOC83
Secondary outcomeCount of participants· Through Day 5

Number of Participants With a Safety Outcome Through Day 5

GroupValue (Participants)
Aviptadil + SOC146
Placebo + SOC129
Secondary outcomeCount of participants· Through Day 28

Number of Participants With a Safety Outcome Through Day 28

GroupValue (Participants)
Aviptadil + SOC181
Placebo + SOC172
Secondary outcomeCount of participants· Through Day 180

Number of Participants Who Died Through Day 180

GroupValue (Participants)
Aviptadil + SOC90
Placebo + SOC86

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Aviptadil + SOCArm includes all participants who received Aviptadil, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.90 / 23125 / 231200 / 231
Placebo + SOCArm includes all participants who received Aviptadil Placebo, and were randomized under strata 1, 2, and 4 from the master protocol (NCT04843761) Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.86 / 23023 / 230176 / 230

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Refer to the master protocol (NCT04843761) Exclusion Criteria: Refer to the master protocol (NCT04843761) Additional Exclusion Criteria: * Refractory hypotension * Severe diarrhea * Current C. difficile infection * Pregnancy or current breast-feeding * End-stage liver disease

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