NCT04477993: RUXO-COVID

Ruxolitinib for Acute Respiratory Disorder Syndrome Due to COVID-19

Terminated Phase 2, PHASE3 Last updated 8 April 2021

What this trial tests

Phase 2, PHASE3 trial testing Janus Kinase Inhibitor (ruxolitinib) in Severe Acute Respiratory Syndrome Coronavirus 2 in 5 participants. Terminated before completion.

Timeline

14 August 2020

Primary endpoint
29 March 2021

29 March 2021

Quick facts

Lead sponsor	Vanderson Geraldo Rocha
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	5
Start date	14 August 2020
Primary completion	29 March 2021
Estimated completion	29 March 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Janus Kinase Inhibitor (ruxolitinib) — full drug profile →
• Placebo

Conditions studied

• Severe Acute Respiratory Syndrome Coronavirus 2 — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 →
• SARS-CoV2 — all drugs for SARS-CoV2 →

Sponsor

Vanderson Geraldo Rocha — full company profile →

Who can join

Adults 18 to 95, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2 or SARS-CoV2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.

Publications & conference data

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

1. COVID-19 and Cancer: Current Challenges and Perspectives.
   Bakouny Z, Hawley JE, Choueiri TK, Peters S, et al · · 2020 · cited 201× · PMID 33049215 · DOI 10.1016/j.ccell.2020.09.018
2. Endothelium Infection and Dysregulation by SARS-CoV-2: Evidence and Caveats in COVID-19.
   Bernard I, Limonta D, Mahal LK, Hobman TC. · · 2020 · cited 128× · PMID 33375371 · DOI 10.3390/v13010029
3. JAK-STAT Pathway Inhibition and their Implications in COVID-19 Therapy.
   Satarker S, Tom AA, Tom AA, Shaji RA, et al · · 2021 · cited 117× · PMID 33245005 · DOI 10.1080/00325481.2020.1855921
4. 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
5. 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
6. A Decade of JAK Inhibitors: What Have We Learned and What May Be the Future?
   Liu C, Kieltyka J, Fleischmann R, Gadina M, et al · · 2021 · cited 49× · PMID 34180156 · DOI 10.1002/art.41906
7. Inflammatory pathways in COVID-19: Mechanism and therapeutic interventions.
   Jiang Y, Zhao T, Zhou X, Xiang Y, et al · · 2022 · cited 44× · PMID 35923762 · DOI 10.1002/mco2.154
8. Cytokine Storm Syndrome in SARS-CoV-2 Infections: A Functional Role of Mast Cells.
   Hafezi B, Chan L, Knapp JP, Karimi N, et al · · 2021 · cited 41× · PMID 34359931 · DOI 10.3390/cells10071761