NCT04373044

Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19

Terminated Phase 2 Last updated 26 May 2021

What this trial tests

Phase 2 trial testing Baricitinib in Symptomatic COVID-19 Infection Laboratory-Confirmed in 6 participants. Terminated before completion.

Timeline

1 May 2020

Primary endpoint
12 May 2021

12 May 2021

Quick facts

Lead sponsor	University of Southern California
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	6
Start date	1 May 2020
Primary completion	12 May 2021
Estimated completion	12 May 2021
Sites	2 locations across United States

Drugs / interventions tested

• Baricitinib (baricitinib) — full drug profile →
• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
• Placebo Administration — full drug profile →

Conditions studied

• Symptomatic COVID-19 Infection Laboratory-Confirmed — all drugs for Symptomatic COVID-19 Infection Laboratory-Confirmed →

Sponsor

University of Southern California

Who can join

18 and older, any sex, with Symptomatic COVID-19 Infection Laboratory-Confirmed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies the effect of baricitinib in combination with antiviral therapy for the treatment of patients with moderate or severe coronavirus disease-2019 (COVID-19). Treatment with antiviral medications such as hydroxychloroquine, lopinavir/ritonavir, and/or remdesivir may act against infection caused by the virus responsible for COVID-19. Baricitinib may reduce lung inflammation. Giving baricitinib in combination with antiviral therapy may reduce the risk of the disease from getting worse and may help prevent the need for being placed on a ventilator should the disease worsen compared to antiviral therapy alone.

Publications & conference data

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

1. Cytokine storm and leukocyte changes in mild versus severe SARS-CoV-2 infection: Review of 3939 COVID-19 patients in China and emerging pathogenesis and therapy concepts.
   Wang J, Jiang M, Chen X, Montaner LJ. · · 2020 · cited 551× · PMID 32534467 · DOI 10.1002/jlb.3covr0520-272r
2. Drug repurposing approach to fight COVID-19.
   Singh TU, Parida S, Lingaraju MC, Kesavan M, et al · · 2020 · cited 299× · PMID 32889701 · DOI 10.1007/s43440-020-00155-6
3. Artificial intelligence in COVID-19 drug repurposing.
   Zhou Y, Wang F, Tang J, Nussinov R, et al · · 2020 · cited 294× · PMID 32984792 · DOI 10.1016/s2589-7500(20)30192-8
4. Targeting JAK-STAT Signaling to Control Cytokine Release Syndrome in COVID-19.
   Luo W, Li YX, Jiang LJ, Chen Q, et al · · 2020 · cited 217× · PMID 32580895 · DOI 10.1016/j.tips.2020.06.007
5. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
6. Remdesivir: Review of Pharmacology, Pre-clinical Data, and Emerging Clinical Experience for COVID-19.
   Jorgensen SCJ, Kebriaei R, Dresser LD. · · 2020 · cited 171× · PMID 32446287 · DOI 10.1002/phar.2429
7. JAK inhibition reduces SARS-CoV-2 liver infectivity and modulates inflammatory responses to reduce morbidity and mortality.
   Stebbing J, Sánchez Nievas G, Falcone M, Youhanna S, et al · · 2021 · cited 164× · PMID 33187978 · DOI 10.1126/sciadv.abe4724
8. Baricitinib: A Review of Pharmacology, Safety, and Emerging Clinical Experience in COVID-19.
   Jorgensen SCJ, Tse CLY, Burry L, Dresser LD. · · 2020 · cited 142× · PMID 32542785 · DOI 10.1002/phar.2438