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NCT04435522

Maraviroc in Patients With Moderate and Severe COVID-19

Completed Phase 1 Results posted Last updated 29 April 2024
What this trial tests

Phase 1 trial testing Maraviroc in COVID in 9 participants. Completed in 31 December 2020.

Timeline
1 October 2020
Primary endpoint
31 December 2020
31 December 2020

Quick facts

Lead sponsorRhode Island Hospital
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date1 October 2020
Primary completion31 December 2020
Estimated completion31 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rhode Island Hospital

Who can join

Adults 18 to 99, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Completion Primary · 7 days

Rate of subjects who complete the 7-day course of Maraviroc (or shorter if discharged from hospital prior to 7 days) without discontinuation for serious adverse event or death.

GroupValue95% CI
Maraviroc Treatment7
Clinical Improvement at Day 7 Primary · 7 days

Percent of patients at Day 7 from enrollment achieving reduction of two points on a seven-category ordinal scale (defined below). Ordinal scale: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities OR hospitalized pending disposition, not requiring COVID-related care; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilat

GroupValue95% CI
Maraviroc Group3
Mortality Secondary · 28 days

7-, 14- and 28-day all-cause-mortality

7-Day Mortality
GroupValue95% CI
Maraviroc Treatment0
14-Day Mortality
GroupValue95% CI
Maraviroc Treatment0
28-Day Mortality
GroupValue95% CI
Maraviroc Treatment0
Median Time to >= 2 Point Improvement in Clinical Score. Secondary · 28 Days

If no clinical improvement of \>=2 points met by day 28, patient outcome censored

GroupValue95% CI
Maraviroc Treatment85 – 28

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over 35 days from day of enrollement.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Maraviroc Group
Serious: 1/9 (11%)
Deaths: 2/9

Serious adverse events (1 terms)

ReactionSystemMaraviroc Group
DeathCardiac disorders
Other adverse events (2 terms — click to expand)

ReactionSystemMaraviroc Group
NauseaGastrointestinal disorders
TransaminitisGastrointestinal disorders

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT04435522 adverse events section.

Sponsor's own description

Maraviroc, a C-C Chemokine Receptor 5 (CCR5) antagonist, is well-tolerated without significant side effects in its current use in patients with HIV. CCR5 antagonism prior to the 'second wave' of inflammatory mediator expression in SARS-CoV-2 may reverse lymphoid depletion and may alter cell trafficking of inflammatory cells, both increasing viral control capacity and dampening damage to lung tissue, respectively. This study seeks to establish whether one week of treatment with Maraviroc, used at its approved dosage for HIV, is safe and tolerable in patients with SARS-CoV-2.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CCL5/CCR5 axis in human diseases and related treatments.
    Zeng Z, Lan T, Wei Y, Wei X. · · 2022 · cited 254× · PMID 34514075 · DOI 10.1016/j.gendis.2021.08.004
  2. Role of chemokine systems in cancer and inflammatory diseases.
    Li H, Wu M, Zhao X. · · 2022 · cited 85× · PMID 35702353 · DOI 10.1002/mco2.147
  3. Cytokines and Chemokines in SARS-CoV-2 Infections-Therapeutic Strategies Targeting Cytokine Storm.
    Pum A, Ennemoser M, Adage T, Kungl AJ. · · 2021 · cited 70× · PMID 33445810 · DOI 10.3390/biom11010091
  4. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  5. A regulatory T cell signature distinguishes the immune landscape of COVID-19 patients from those with other respiratory infections.
    Vick SC, Frutoso M, Mair F, Konecny AJ, et al · · 2021 · cited 46× · PMID 34757794 · DOI 10.1126/sciadv.abj0274
  6. Potential Anti-SARS-CoV-2 Therapeutics That Target the Post-Entry Stages of the Viral Life Cycle: A Comprehensive Review.
    Al-Horani RA, Kar S. · · 2020 · cited 33× · PMID 32993173 · DOI 10.3390/v12101092
  7. Blocking inflammation on the way: Rationale for CXCR2 antagonists for the treatment of COVID-19.
    Koenig LM, Boehmer DFR, Metzger P, Schnurr M, et al · · 2020 · cited 29× · PMID 32678432 · DOI 10.1084/jem.20201342
  8. Rationale of using the dual chemokine receptor CCR2/CCR5 inhibitor cenicriviroc for the treatment of COVID-19.
    Files DC, Tacke F, O'Sullivan A, Dorr P, et al · · 2022 · cited 24× · PMID 35749425 · DOI 10.1371/journal.ppat.1010547

Verify or expand the search:

Other trials of Maraviroc

Trials testing the same drug.

Other recruiting trials for COVID

Currently open trials in the same condition.

Other Rhode Island Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04435522.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing