Trial Outcomes & Findings for Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial) (NCT NCT06729593)

Last Updated: 2025-10-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

87 participants

Primary outcome timeframe

Status on Day 90

Results posted on

2025-10-09

Participant Flow

This substudy presents analysis for Remdesivir vs Remdesivir Placebo. Per protocol, this comparison was conducted among the pooled cohort of participants who were randomized to receive active Remdesivir or Remdesvir Placebo within randomization strata 1 and 3 of the master protocol.

Participant milestones

Participant milestones
Measure	Remdesivir + SOC Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Overall Study STARTED	44	43
Overall Study COMPLETED	44	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remdesivir + SOC n=44 Participants Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=43 Participants Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants	31 Participants n=4 Participants	60 Participants n=27 Participants
Age, Categorical >=65 years	15 Participants n=93 Participants	12 Participants n=4 Participants	27 Participants n=27 Participants
Age, Continuous	54.6 years STANDARD_DEVIATION 14.3 • n=93 Participants	55.9 years STANDARD_DEVIATION 12.6 • n=4 Participants	55.3 years STANDARD_DEVIATION 13.4 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	28 Participants n=4 Participants	58 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=93 Participants	16 Participants n=4 Participants	30 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=93 Participants	27 Participants n=4 Participants	57 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized Race · White	19 Participants n=93 Participants	24 Participants n=4 Participants	43 Participants n=27 Participants
Race/Ethnicity, Customized Race · More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Race · Only ethnicity (race unknown)	12 Participants n=93 Participants	10 Participants n=4 Participants	22 Participants n=27 Participants

PRIMARY outcome

Timeframe: Status on Day 90

Population: 1 participant in the remdesivir arm did not have the day 90 status available to compute the primary endpoint. This participant was excluded from the analysis.

Outcome measures

Outcome measures
Measure	Remdesivir + SOC n=43 Participants Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=43 Participants Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 4 = not hospitalized but either on supplemental oxygen or not at home	7 Participants	3 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 1 = at home and off oxygen (recovered) for at least 77 days	5 Participants	8 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 2 = at home and off oxygen for 49-76 days	7 Participants	6 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 3 = at home and off oxygen for 1-48 days	4 Participants	5 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 5 = hospitalized or in hospice care	3 Participants	1 Participants
Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 category 6 = died	17 Participants	20 Participants

SECONDARY outcome

Timeframe: Through Day 90

Outcome measures

Outcome measures
Measure	Remdesivir + SOC n=44 Participants Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=43 Participants Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants Who Died Through Day 90	17 Participants	20 Participants

SECONDARY outcome

Timeframe: Through Day 5

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

Outcome measures

Outcome measures
Measure	Remdesivir + SOC n=44 Participants Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=43 Participants Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants With a Safety Outcome Through Day 5	25 Participants	25 Participants

SECONDARY outcome

Timeframe: Through Day 28

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

Outcome measures

Outcome measures
Measure	Remdesivir + SOC n=44 Participants Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=43 Participants Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants With a Safety Outcome Through Day 28	36 Participants	34 Participants

SECONDARY outcome

Timeframe: Through Day 180

Outcome measures

Outcome measures
Measure	Remdesivir + SOC n=44 Participants Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=43 Participants Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Number of Participants Who Died Through Day 180	19 Participants	21 Participants

Adverse Events

Remdesivir + SOC

Serious events: 9 serious events

Other events: 27 other events

Deaths: 19 deaths

Placebo + SOC

Serious events: 2 serious events

Other events: 31 other events

Deaths: 21 deaths

Serious adverse events

Serious adverse events
Measure	Remdesivir + SOC n=44 participants at risk Arm includes all participants who received Remdesivir and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir: Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.	Placebo + SOC n=43 participants at risk Arm includes all participants who received Remdesivir Placebo and were randomized under strata 1 and 3 from the master protocol (NCT04843761). Remdesivir Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days. Corticosteroid: In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Infections and infestations Herpes zoster	2.3% 1/44 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/43 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Investigations Computerised tomogram thorax abnormal	2.3% 1/44 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/43 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Psychiatric disorders Delirium	2.3% 1/44 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/43 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	2.3% 1/44 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/43 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	2.3% 1/44 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/43 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Respiratory, thoracic and mediastinal disorders Pneumothorax	9.1% 4/44 • Number of events 4 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	4.7% 2/43 • Number of events 2 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Skin and subcutaneous tissue disorders Rash	2.3% 1/44 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/43 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment
Vascular disorders Hypotension	2.3% 1/44 • Number of events 1 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment	0.00% 0/43 • All-cause mortality collected through Day 180 Serious adverse events collected through Day 90 Other adverse events (not serious): Combined reporting of infusion reactions on Study days 0 through 9 AND any other Adverse Events through Study Day 28. Adverse events were collected irrespective of mono or dual therapy assignment

Other adverse events

Additional Information

Shweta Sharma Mistry

University of Minnesota

Phone: 612-626-9021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place