AzTrials
AzTrials

COVID-19Phase 2I-SPY_COVIDNCT04488081

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

A Phase 2 study testing Remdesivir, Imatinib Mesylate and Dexamethasone in people with COVID-19, run by QuantumLeap Healthcare Collaborative at 36 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
Remdesivir, Imatinib Mesylate and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
36 sitesUnited States
Study dates
31 Jul 2020to 31 Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
  • Male or Female, at least 18 years old
  • Admitted to the hospital and placed on high flow oxygen (≥6L by nasal cannula or mask delivery system) or intubated for the treatment of (established or presumed) COVID-19.
  • Informed consent provided by the patient, LAR or health care proxy.
  • Confirmation of SARS-CoV-2 infection by PCR or Rapid antigen testing for SARS- CoV-2 infection prior to randomization.

Who cannot join

  • Pregnant or breastfeeding women (must be documented by a pregnancy test during hospitalization)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history.
  • Comfort measures only.
  • Acute liver disease, or chronic liver disease with a Child-Pugh score greater than 11.
  • Resident for more than six months at a skilled nursing facility.
  • Estimated mortality greater than 50% over the next six months from underlying chronic conditions.
Show all 12Show fewer
  • Time since requirement for high flow oxygen or ventilation greater than 5 days.
  • Anticipated transfer to another hospital which is not a study site within 72 hours.
  • Patients with either end-stage kidney disease or acute kidney injury who are on dialysis.
  • Co-enrollment in clinical trials of pharmacologic agents requiring an IND.
  • On 3 or more vasopressors.
  • Pre-existing heart failure with a known left ventricular ejection fraction <25% or unstable angina pectoris.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106

  • University of Miami

    Coral Gables, Florida, 33124

  • UC Davis Medical Center

    Davis, California, 95817

  • DHR Health

    Edinburg, Texas, 78539

  • University of Florida

    Gainesville, Florida, 32608

  • Corewell Health

    Grand Rapids, Michigan, 49503

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • UC Irvine Medical Center

    Irvine, California, 92868

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Kaiser LAMC

    Los Angeles, California, 90027

  • University of Southern California

    Los Angeles, California, 90033

  • WVU Medicine

    Morgantown, West Virginia, 26506

  • Virtua Mount Holly Hospital

    Mount Holly, New Jersey, 08060

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • University of Pennsylvania (U Penn)

    Philadelphia, Pennsylvania, 19104

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California San Francisco (UCSF)

    San Francisco, California, 94115

  • Sanford Health

    Souix Falls, South Dakota, 57109

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Stamford Health

    Stamford, Connecticut, 06904

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Virtua Voorhees Hospital

    Voorhees Township, New Jersey, 08043

  • Georgetown University

    Washington D.C., District of Columbia, 20007

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

  • Lankenau Medical Center (Mainline Health)

    Wynnewood, Pennsylvania, 19096

  • Main Line Health - Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: I-SPY COVID TRIAL: An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients

The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.

Read the detailed description

This platform trial will provide access to repurposed and investigational agents for critically ill patients infected with SARS-CoV-2 who have severe or life-threatening COVID-19. The main focus of this trial is a platform study for identifying effective agents for the treatment of COVID-19. Any critically ill patient with known or presumed COVID-19 will be automatically entered into the screening phase of the trial until SARS-CoV-2 infection is confirmed. Basic data will be assembled for each patient (such as ventilatory status and survival). If interested in the therapeutic portion of the trial, potential participants will be asked to sign a consent form describing the backbone treatment and the two specific investigational agent arms to which they may be randomized. The primary endpoints will be time to recover to a durable level 4 (or less) on the WHO COVID-19 ordinal scale for clinical improvement and time to mortality (death). For this trial, a durable level 4 is defined as at least 48 hours at COVID level 4 or less (nasal prongs oxygen) without returning to high flow oxygen or intubation. Acute care facility resource utilization will be automatically calculated (total length of stay in a critical care setting, days intubated, and survival). Any change in status, including intubation, extubation, death or discharge, will be recorded and verified by the attending physician.

Patients will be evaluated based on their initial status (ventilation at entry vs. high flow oxygen). Exploratory biomarkers will be evaluated over time (ARDS phenotypes and other proposed markers) to facilitate clinical learning. A maximum of two investigational arms may be open at a time. The anticipated accrual will be 50 patients per week. The maximum number of participants assigned to an arm without graduation will be 125 patients. Agents can be dropped for futility after enrollment of 40 patients. As the trial proceeds and a better understanding of the underlying mechanisms of the COVID-19 illness emerges, expanded biomarker and data collection can be added as needed to further elucidate how agents are or are not working. The study design features comparison of investigational agent efficacy using a Bayesian design, which will allow the detection of strong efficacy signals with the fewest possible patients. Initially the control will be patients given current standard of care (supportive care for ARDS, including lung protective ventilation and remdesivir and dexamethasone as backbone therapy). As other treatments (for example, anticoagulation) become part of standard supportive care across sites, these will be added to the backbone therapy. If an agent meets the threshold for graduation the company leadership will be informed as will the FDA. The arm with the graduated agent will cease to enroll, allowing a new arm with a different investigational agent to be added.

Every trial participant will have blood collected at trial enrollment, day 3, and day 7 for pre-specified biomarker and DNA and RNA analysis. Additional biomarkers can be added as the trial proceeds. Patient outcomes will also be evaluated on the basis of whether patients are ventilated initially or not.

Observational Component:

Initially, all COVID-19 confirmed patients who started high-flow oxygen (WHO COVID-19 level 5; ≥6L oxygen by nasal prongs or mask) were entered in an Observational Component which collected data via extraction of medical records. Patients in this Observational Component also had their daily COVID status and drug administration form CRFs completed. An expanded Observational Study will replace the original Observational Component. The expanded observational study (Supplement 1) will collect blood sample(s) and clinical data from ARDS and AHRF patients (including COVID ARDS patients) to test the feasibility of quantifying a set of biomarkers that will allow each patient to be classified into either a hyper-inflammatory or hypo-inflammatory subtype in real time. If treatment of these critically ill ICU patients is to be guided by subtype classification, it is essential that the operational time for classification is as quick as possible.

Conditions
COVID-19
Being tested
Remdesivir, Imatinib Mesylate, Dexamethasone, Cenicriviroc, Icatibant
Keywords
COVID-19, severe disease, Platform Trial, Acute Respiratory Distress Syndrome, ARDS, SARS-COV-2, AHRF, Acute Hypoxemic Respiratory Failure
Medical subject headings
COVID-19, Disease, Respiratory Distress Syndrome, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemdesivirDrug

    Also called GS-5734

    Participants who receive remdesivir as part of their standard of care will be administered remdesivir by IV for up to ten days. Remdesivir 200mg loading dose on day 1, followed by 100mg IV once daily maintenance doses for 4 or 9 days.

  • Imatinib MesylateDrug

    Subjects will be administered 800 mg on Day 1 orally, in divided doses of 400 mg administered twice per day. 400 mg daily will be administered orally for the following 9 days or until discharge, whichever is sooner.

  • DexamethasoneDrug

    6 mg intravenous of oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.

  • CenicrivirocDrug

    Oral, loading 300 mg qAM followed by 150 mg qPM, 12 hours apart on day 1, then 150 mg BID for total of 14 to 28 days depending on date of hospital discharge.

  • IcatibantDrug

    Also called Firazyr

    Subcutaneous, a safety run-in for the first 10 subjects was conducted using a regimen of 30 mg q8h × 3 days. All subsequent subjects received drug at 30 mg q8h x 6 days.

  • ApremilastDrug

    Also called Otezla

    oral, 30 mg bid × 14 days.

  • dornase alfaBiological

    Also called Pulmozyme

    For Non-intubated subjects: 2.5 mg BID until hospital discharge, improvement to room air (or baseline oxygen use prior to illness) for 24 hours, or total of 14 days of study drug, whichever comes first.

    For intubated subjects: 5.0 mg BID in 10 mL normal saline until extubation or 14 days, whichever comes first. If intubated for less than 14 days, extubated subjects received 2.5 mg BID for a total Dornase treatment of 14 days, or until hospital discharge, whichever comes first.

  • CelecoxibDrug

    Also called celebrex

    Oral: 400 mg BID for 7 days.

  • FamotidineDrug

    Also called Pepcid

    Oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.

  • IC14Biological

    intravenous, 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4

  • AviptadilDrug

    Also called Zyesami

    Inhalation via nebulizer, 100 µg three times (TID) daily for a maximum of 14 days

  • narsoplimabBiological

    Also called OMS721

    Dosed at 4 mg/kg, given as a 30-minute intravenous infusion (up to a maximum of 370 mg per infusion) twice weekly for a total of four weeks (i.e. 9 doses) or until hospital discharge whichever comes first.

  • CyproheptadineDrug

    Also called periactin

    4 mg tablet, with dosing regimen of 8 mg every 8 hours daily for ten (10) days. If the patient weighs less than 48 kg, the regimen is 6 mg every 8 hours daily for ten (10) days. If the participant was discharged before completion of this dosing regimen the drug was not continued.

  • CyclosporineDrug

    Also called CsA

    Modified CsA at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.

Study groups in NCT04488081
Study groupRoleWhat they receive
Control/Backbone - Remdesivir and Dexamethasone (CLOSED)Active comparatorParticipants randomized to the backbone control will be given standard of care (supportive care for ARDS, including remdesivir and, if needed, lung protective ventilation). Because dexamethasone was shown to have benefit in at least one large randomized clinical trial, patients in the backbone control arm should receive dexamethasone for a total of 10 days during the hospitalization or until or hospital discharge. Remdesivir (intravenous): 200-mg loading dose on day 1, followed by a daily maintenance dose of 100-mg on days 2 through 10. Dexamethasone (intravenous): 6 mg intravenous or oral dexamethasone once daily up to 10 days or equivalent for alternate corticosteroid if dexamethasone unavailable.
Receives: Drug: Remdesivir; Drug: Dexamethasone
Imatinib + Standard of Care (CLOSED)ExperimentalSubjects will be administered standard of care + 800 mg imatinib on Day 1 orally, in divided doses of 400 mg administered twice per day. 400 mg daily will be administered orally for the following 9 days or until discharge, whichever is sooner.
Receives: Drug: Remdesivir; Drug: Imatinib Mesylate; Drug: Dexamethasone
Cenicriviroc + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + cenicriviroc orally , loading 300 mg qAM followed by 150 mg qPM, 12 hours apart on day 1, then 150 mg BID for total of 14 to 28 days depending on date of hospital discharge.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Drug: Cenicriviroc
Icatibant + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + icatibant subcutaneously, a safety run-in for the first 10 subjects was conducted using a regimen of 30 mg q8h × 3 days. All subsequent subjects received drug at 30 mg q8h x 6 days.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Drug: Icatibant
Apremilast + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + apremilast orally , 30 mg bid × 14 days.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Drug: Apremilast
Dornase + Standard of Care (CLOSED)ExperimentalFor Non-intubated subjects: Subjects administered standard of care + dornase, 2.5 mg BID until hospital discharge, improvement to room air (or baseline oxygen use prior to illness) for 24 hours, or total of 14 days of study drug, whichever comes first. For intubated subjects: Subjects administered standard of care + dornase, 5.0 mg BID in 10 mL normal saline until extubation or 14 days, whichever comes first. If intubated for less than 14 days, extubated subjects received 2.5 mg BID for a total Dornase treatment of 14 days, or until hospital discharge, whichever comes first.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Biological: dornase alfa
Celecoxib/famotidine + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + celecoxib/famotidine orally . Celecoxib, oral: 400 mg BID for 7 days. Famotidine, oral: High dose 80 mg QID for 7 days followed by 40 mg BID for a course of 14 days.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Drug: Celecoxib; Drug: Famotidine
IC14 + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + IC14 intravenously , 4 mg/kg on day 1, followed by 2 mg/kg on days 2, 3, 4
Receives: Drug: Remdesivir; Drug: Dexamethasone; Biological: IC14
Narsoplimab + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + narsoplimab dosed at 4 mg/kg, given as a 30-minute intravenous infusion (up to a maximum of 370 mg per infusion) twice weekly for a total of four weeks (i.e. 9 doses) or until hospital discharge whichever comes first.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Biological: narsoplimab
Aviptadil + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + aviptadil (inhalation via nebulizer), 100 µg three times (TID) daily for a maximum of 14 days
Receives: Drug: Remdesivir; Drug: Dexamethasone; Drug: Aviptadil
Cyproheptadine + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + cyproheptadine via 4 mg tablet, with dosing regimen of 8 mg every 8 hours daily for ten (10) days.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Drug: Cyproheptadine
Cyclosporine + Standard of Care (CLOSED)ExperimentalSubjects administered standard of care + modified cyclosporine at an oral dose of 5mg/kg per day administered in two divided doses daily for 5-days.
Receives: Drug: Remdesivir; Drug: Dexamethasone; Drug: Cyclosporine
Imatinib (PENDING ACTIVATION)ExperimentalSubjects will be administered 800 mg on Day 1 orally, in divided doses of 400 mg administered twice per day. 400 mg daily will be administered orally for the following 9 days or until discharge, whichever is sooner.
Receives: Drug: Imatinib Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.

    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:

    1. No clinical or virologic evidence of infection
    2. Not hospitalized, no limitations on activities;
    3. Not hospitalized, limitation on activities;
    4. Hospitalized, not requiring supplemental oxygen;
    5. Hospitalized, requiring supplemental oxygen (< 6L by nasal cannula or mask delivery system);
    6. Hospitalized, on non-invasive ventilation or high flow oxygen devices (≥6L per minute, mask or intranasal cannula);
    7. Hospitalized, on invasive mechanical ventilation;
    8. Hospitalized, ventilation plus additional organ support-pressors, RRT, ECMO
    9. Death.

    Measured: Up to 28 days

Secondary outcomes (4)

  1. Mortality

    • 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.

    Measured: Up to 28 days

  2. Improvement in disease severity

    • 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)

    Measured: Up to 60 days

  3. Health care utilization

    Ventilator-free days

    Measured: Up to 28 days

  4. Safety: Frequency of serious AEs

    • 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.

    Measured: Up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start31 Jul 2020
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Platform Trial, Bayesian Design, from 2 arms up to 8 arms
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04488081
Sponsor's protocol ID
I-SPY-COVID
Acronym
I-SPY_COVID
Status last verified
Mar 2026
First submitted
14 Jul 2020
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We will share data on a case by case basis with appropriate IRB review and review by our Data Safety Monitoring Comittee.

Publications

  • Files DC, Matthay MA, Calfee CS, Aggarwal NR, Asare AL, Beitler JR, Berger PA, Burnham EL, Cimino G, Coleman MH, Crippa A, Discacciati A, Gandotra S, Gibbs KW, Henderson PT, Ittner CAG, Jauregui A, Khan KT, Koff JL, Lang J, LaRose M, Levitt J, Lu R, McKeehan JD, Meyer NJ, Russell DW, Thomas KW, Eklund M, Esserman LJ, Liu KD; ISPY COVID Adaptive Platform Trial Network; undefined. I-SPY COVID adaptive platform trial for COVID-19 acute respiratory failure: rationale, design and operations. BMJ Open. 2022 Jun 6;12(6):e060664. doi: 10.1136/bmjopen-2021-060664.

    PubMed 35667714

  • Auld SC, Youssef FA, Albertson TE, Beitler JR, Berger PA, Burnham EL, Cobb N, Friedman E, Gandotra S, Gibbs KW, Hayanga J, Hyzy R, Khan MMHS, Koff JL, Lee RA, Meyer NJ, Obermiller T, Quill C, Robinson P, Samavedam S, Wei KK, Wunderink RG, Russell DW, Eklund M, Calfee CS, Matthay MA, Files DC, Liu KD, Esserman LJ. The Effects of Cyproheptadine on Severe COVID-19 From the I-SPY COVID Adaptive Platform Trial. CHEST Crit Care. 2025 Dec;3(4):100201. doi: 10.1016/j.chstcc.2025.100201. Epub 2025 Aug 6.

    PubMed 42799508

  • Mabrey FL, Martin TR, Calfee CS, Liu KD, LaCombe B, Brown-Swigart L, Discacciati A, Eklund M, Heckbert SR, Matthay MA, Esserman L, Wurfel MM. Anti-CD14 treatment in patients with severe COVID-19: Clinical and biological effects in a Phase 2 randomized open-label adaptive platform clinical trial. CHEST Crit Care. 2025 Mar;3(1):100117. doi: 10.1016/j.chstcc.2024.100117. Epub 2024 Dec 9.

    PubMed 40462830

  • Pomponio R, Peterson RA, Owusu M, Slaughter S, Melgar S, Jolley SE, Burnham EL. Phosphatidylethanol measures in patients with severe COVID-19-associated respiratory failure identify a subset with alcohol misuse. Alcohol Clin Exp Res (Hoboken). 2025 Jan;49(1):165-174. doi: 10.1111/acer.15495. Epub 2024 Nov 26.

    PubMed 39592213

  • I-SPY COVID Consortium. Report of the first seven agents in the I-SPY COVID trial: a phase 2, open label, adaptive platform randomised controlled trial. EClinicalMedicine. 2023 Apr;58:101889. doi: 10.1016/j.eclinm.2023.101889. Epub 2023 Mar 3.

    PubMed 36883141

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Remdesivir, Imatinib Mesylate and Dexamethasone in people with COVID-19, run by QuantumLeap Healthcare Collaborative at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19. (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04488081, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in