Trial · Interventional

CompletedPhase 3Results postedRegistry data

ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

Short name TESICO

NCTNCT04843761Other id015 / ACTIV-3b

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 473 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: 14 Apr 2021
Last update posted: 24 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

Ph 3
TESICO
NCT04843761
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 different drugs 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 either a study drug plus current standard of care (SOC), or with placebo plus current SOC. Substudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606) Substudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)

Interventions

RemdesivirBiological
Remdesivir PlaceboDrug
AviptadilBiological
Aviptadil PlaceboDrug
CorticosteroidDrug

Arms10

Experimental
Stratum 1 - Aviptadil + Remdesivir + SOC
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
Experimental
Stratum 1 - Aviptadil + Remdesivir Placebo + SOC
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
Experimental
Stratum 1 - Aviptadil Placebo + Remdesivir + SOC
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
Placebo comparator
Stratum 1 - Aviptadil Placebo + Remdesivir Placebo + SOC
Eligible for both Aviptadil and Remdesivir and no prior use of Remdesivir Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)
Experimental
Stratum 2 - Aviptadil + SOC
Eligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
Placebo comparator
Stratum 2 - Aviptadil Placebo + SOC
Eligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
Experimental
Stratum 3 - Remdesivir + SOC
Eligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
Placebo comparator
Stratum 3 - Remdesivir Placebo + SOC
Eligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)
Experimental
Stratum 4 - Aviptadil + SOC
Eligible for Aviptadil and prior/current use of Remdesivir Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)
Placebo comparator
Stratum 4 - Aviptadil Placebo + SOC
Eligible for Aviptadil and prior/current use of Remdesivir Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)

Primary outcomes1

Outcomes the sponsor listed as primary.

Substudy Analysis Cohorts
Time frame · Screening, within 24 hours
Registry description
The primary analysis for each agent was to pool across applicable groups to compare each agent vs. matched placebo. Refer to the agent-specific records for results by agent (H1 \[Aviptadil\]: NCT06729606; H2 \[Remdesivir\]: NCT06729593).

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· Screening, within 24 hours

Substudy Analysis Cohorts

Group	Value (Participants)
Stratum 1 - Aviptadil + Remdesivir	18
Stratum 1 - Aviptadil +Remdesivir Placebo	21
Stratum 1 - Aviptadil Placebo + Remdesivir	25
Stratum 1 - Aviptadil Placebo + Remdesivir Placebo	21
Stratum 2 - Aviptadil	12
Stratum 2 - Aviptadil Placebo	11
Stratum 3 - Remdesivir	0
Stratum 3 - Remdesivir Placebo	0
Stratum 4 - Aviptadil	183
Stratum 4 - Aviptadil Placebo	180

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Stratum 1 - Aviptadil + RemdesivirEligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)	0 / 0	0 / 0	0 / 0
Stratum 1 - Aviptadil +Remdesivir PlaceboEligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)	0 / 0	0 / 0	0 / 0
Stratum 1 - Aviptadil Placebo + RemdesivirEligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)	0 / 0	0 / 0	0 / 0
Stratum 1 - Aviptadil Placebo + Remdesivir PlaceboEligible for both Aviptadil and Remdesivir and no prior use of Remdesivir * Participants enrolled in Stratum 1 were analyzed in both substudies (H1: NCT06729606; H2: NCT06729593)	0 / 0	0 / 0	0 / 0
Stratum 2 - AviptadilEligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)	0 / 0	0 / 0	0 / 0
Stratum 2 - Aviptadil PlaceboEligible for Aviptadil and Remdesivir contraindicated * Contraindications: eGFR less than 30 or ALT/AST greater than 10x the upper limit of normal * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)	0 / 0	0 / 0	0 / 0
Stratum 3 - RemdesivirEligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection * Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)	0 / 0	0 / 0	0 / 0
Stratum 3 - Remdesivir PlaceboEligible for Remdesivir and Aviptadil contraindicated * Contraindications: refractory hypotension (norepinephrine equivalent greater than or equal to 0.1 mcg/kg/min), severe diarrhea, end-stage liver disease, c-diff infection * Participants enrolled in this arm were analyzed in substudy H2 (NCT06729593)	0 / 0	0 / 0	0 / 0
Stratum 4 - AviptadilEligible for Aviptadil and prior/current use of Remdesivir * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)	0 / 0	0 / 0	0 / 0
Stratum 4 - Aviptadil PlaceboEligible for Aviptadil and prior/current use of Remdesivir * Participants enrolled in this arm were analyzed in substudy H1 (NCT06729606)	0 / 0	0 / 0	0 / 0

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

3 results

Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial.

Brown et al. 2023The Lancet. Respiratory medicinecited by 16

PMID 37348524PMC10527239DOI 10.1016/s2213-2600(23)00147-9PUB-37348524

Rights unknown3 results

Source link See results (3)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedGrundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2. PMID 36695483
DerivedTsiatis AA, Davidian M, Holloway ST. Estimation of the odds ratio in a proportional odds model with censored time-lagged outcome in a randomized clinical trial. Biometrics. 2023 Jun;79(2):975-987. doi: 10.1111/biom.13603. Epub 2021 Dec 17. PMID 34825704

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Signed informed consent. * Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19 (not for purely public health or quarantine purposes). * Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO used to treat acute hypoxemic respiratory failure). * SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization. * Respiratory failure is believed to be due to SARS-CoV-2 pneumonia. Exclusion Criteria: * Known allergy to investigational agent or vehicle. * More than 4 days since initiation of support for respiratory failure. * Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion). * Moribund patient (i.e. not expected to survive 24 hours). * Active use of "comfort care" or other hospice-equivalent SOC. * Expected inability to participate in study procedures. * In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments. * Previous enrollment in TESICO Additional agent-specific criteria also apply, and are listed in the substudy records Substudy H1: Aviptadil for Severely Ill Inpatients With COVID-19 (NCT06729606) Substudy H2: Remdesivir for Severely Ill Inpatients With COVID-19 (NCT06729593)

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