Trial · NCT05780437
AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
NCT05780437, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2024-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial). Trials, record NCT05780437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05780437
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
- NCT number
- NCT05780437
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,455 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- COVID-19
- Interventions
- AZD7442, Placebo, Remdesivir
- First posted
- 2023-03-22
- Last updated
- 2025-02-04
- Results first posted
- 2024-07-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Sustained Recovery | Through Day 90 | The primary endpoint is the proportion of subjects with sustained recovery, which is defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol. Readmission from "home" may occur, and if this occurs within 14 days of the first discharge to "home," then the primary endpoint will not be reached until such time as the participant has been at home for 14 consecutive days. |
| Primary | Number of Participants With an Ordinal Outcome on Day 5 | Status on Day 5 | Ordinal outcome with 7 mutually exclusive categories |
| Secondary | Number of Participants With a Safety Outcome Through Day 5 | Through Day 5 | Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5. Seriousness was based on the definition of the term at 21CFR312.32 AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. \[July 2017\]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening |
| Secondary | Number of Participants With a Safety Outcome Through Day 28 | Through Day 28 | Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28. Seriousness was based on the definition of the term at 21CFR312.32 AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. \[July 2017\]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening |
| Secondary | Number of Participants With a Safety Outcome Through Day 90 | Through Day 90 | Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 90. Seriousness was based on the definition of the term at 21CFR312.32 AEs were graded for severity according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table). |
| Secondary | Number of Participants Who Died From All Causes | Through Day 90 | All-cause Mortality |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Sustained Recovery | Through Day 90 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With an Ordinal Outcome on Day 5 | Status on Day 5 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Safety Outcome Through Day 5 | Through Day 5 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Safety Outcome Through Day 28 | Through Day 28 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Safety Outcome Through Day 90 | Through Day 90 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Died From All Causes | Through Day 90 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Sustained Recovery | AZD7442 Plus SOC | 617 | Participants | ||
| Number of Participants With Sustained Recovery | Placebo Plus SOC | 594 | Participants | ||
| Number of Participants With an Ordinal Outcome on Day 5 | AZD7442 Plus SOC | 7 = Death | 10 | Participants | |
| Number of Participants With an Ordinal Outcome on Day 5 | Placebo Plus SOC | 7 = Death | 13 | Participants | |
| Number of Participants With an Ordinal Outcome on Day 5 | AZD7442 Plus SOC | 6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy | 32 | Participants | |
| Number of Participants With an Ordinal Outcome on Day 5 | Placebo Plus SOC | 6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy | 29 | Participants | |
| Number of Participants With an Ordinal Outcome on Day 5 | AZD7442 Plus SOC | 5 = Non-invasive ventilation or high flow oxygen | 102 | Participants | |
| Number of Participants With an Ordinal Outcome on Day 5 | Placebo Plus SOC | 5 = Non-invasive ventilation or high flow oxygen | 99 | Participants | |
| Number of Participants With an Ordinal Outcome on Day 5 | AZD7442 Plus SOC | 4 = Supplement oxgen (≥4 L/min or ≥4 L/min above baseline, but not high flow oxygen) | 92 | Participants | |
| Number of Participants With an Ordinal Outcome on Day 5 | Placebo Plus SOC | 4 = Supplement oxgen (≥4 L/min or ≥4 L/min above baseline, but not high flow oxygen) | 106 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD7442 Plus SOC | 732 | |
| Overall Study | STARTED | Placebo Plus SOC | 723 | |
| Overall Study | COMPLETED | AZD7442 Plus SOC | 710 | |
| Overall Study | COMPLETED | Placebo Plus SOC | 707 | |
| Overall Study | NOT COMPLETED | AZD7442 Plus SOC | 22 | |
| Overall Study | NOT COMPLETED | Placebo Plus SOC | 16 |
Source ClinicalTrials.gov
Adverse events460
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | AZD7442 Plus SOC | 8 | 710 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Placebo Plus SOC | 5 | 707 | 6 |
| other | Anemia macrocytic | Blood and lymphatic system disorders | AZD7442 Plus SOC | 1 | 710 | 1 |
| other | Anemia macrocytic | Blood and lymphatic system disorders | Placebo Plus SOC | 0 | 707 | 0 |
| other | Anemia of chronic disease | Blood and lymphatic system disorders | AZD7442 Plus SOC | 0 | 710 | 0 |
| other | Anemia of chronic disease | Blood and lymphatic system disorders | Placebo Plus SOC | 1 | 707 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | AZD7442 Plus SOC | 0 | 710 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Placebo Plus SOC | 1 | 707 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | AZD7442 Plus SOC | 1 | 710 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo Plus SOC | 0 | 707 | 0 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD7442 Plus SOC | 61 | 710 |
| Total, all-cause mortality | Placebo Plus SOC | 86 | 707 |
| Total, other adverse events | AZD7442 Plus SOC | 176 | 710 |
| Total, other adverse events | Placebo Plus SOC | 184 | 707 |
| Total, serious adverse events | AZD7442 Plus SOC | 36 | 710 |
| Total, serious adverse events | Placebo Plus SOC | 39 | 707 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35817072 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AZD7442 Plus SOC vs Placebo Plus SOC: Number of Participants With Sustained Recovery | Trial comparisons |
| AZD7442 Plus SOC vs Placebo Plus SOC: Number of Participants With a Safety Outcome Through Day 28 | Trial comparisons |
| AZD7442 Plus SOC vs Placebo Plus SOC: Number of Participants Who Died From All Causes | Trial comparisons |
| AZD7442 Plus SOC vs Placebo Plus SOC: deaths from any cause | Trial comparisons |
| AZD7442 Plus SOC vs Placebo Plus SOC: Number of Participants With a Safety Outcome Through Day 90 | Trial comparisons |
| AZD7442 Plus SOC vs Placebo Plus SOC: Number of Participants With a Safety Outcome Through Day 5 | Trial comparisons |
| AZD7442 Plus SOC vs Placebo Plus SOC: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05780437
GET https://conductscience.org/api/trials/v1/NCT05780437/results?page=2