Trial · NCT04488081
I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
NCT04488081, Phase 2, Active not recruiting, QuantumLeap Healthcare Collaborative
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients. Trials, record NCT04488081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04488081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients
- NCT number
- NCT04488081
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 1,500 participants, estimated
- Lead sponsor
- QuantumLeap Healthcare Collaborative
- Conditions
- COVID-19
- Interventions
- Remdesivir, Imatinib Mesylate, Dexamethasone, Cenicriviroc, Icatibant, Apremilast, dornase alfa, Celecoxib, Famotidine, IC14, Aviptadil, narsoplimab, Cyproheptadine, Cyclosporine
- First posted
- 2020-07-27
- Last updated
- 2026-03-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19. | Up to 28 days | Time to reach a durable COVID-19 level 4 or less or discharge at COVID-level 4 or lower (except for discharge to another hospital), and time to death (mortality). Data will be analyzed for 3 groups: * All * COVID-19 level 6/7 (those intubated immediately) * COVID-19 level 5 (high flow oxygen to start) World Health Organization 9-point ordinal scale: 0\. No clinical or virologic evidence of infection 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen (\< 6L by nasal cannula or mask delivery system); 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices (≥6L per minute, mask or intranasal cannula); 6. Hospitalized, on invasive mechanical ventilation; 7. Hospitalized, ventilation plus additional organ support-pressors, RRT, ECMO 8. Death. |
| Secondary | Mortality | Up to 28 days | * Proportion of patients alive in the treatment and control arm at day 7, 14, 21, and 28 (The proportion of patients alive, i.e., alive and still at risk of both reaching level 4 and death is given by the survival function). * The cumulative incidence function for mortality. |
| Secondary | Improvement in disease severity | Up to 60 days | * Sustained recovery which is defined as time to discharge at COVID-level 4 or lower and not subsequently re-admitted to the hospital or die at Day 28 follow-up if discharged before 28 days, and Day 60 follow-up if discharged between 28 to 60 days. * % of COVID-19 level 5 who never progress to COVID-19 level 6/7 The measure for recovery is defined as time to reach level 4 or less in the World Health Organization COVID-19 scale for at least 48 hours - without returning to high flow oxygen or intubation, or discharge at COVID level 4 or less except for discharge to another hospital. (0 being minimum and 8 being maximum) |
| Secondary | Health care utilization | Up to 28 days | Ventilator-free days |
| Secondary | Safety: Frequency of serious AEs | Up to 60 days | * Total grade 3 or higher AEs by arm and total number of patients with grade 3 or higher AEs by arm. * Total grade 3 or higher AEs of special interest by arm and total number of patients with grade 3 or higher AEs of special interest by arms (based upon lab assessments) All AEs will be identified and assessed for severity using the National Cancer Institute - Common Terminology Criteria for Adverse Events v5.0 which provides a grading scale for each AE listed. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04488081
GET https://conductscience.org/api/trials/v1/NCT04488081/registered