NCT04319900

Clinical Trial of Favipiravir Tablets Combine With Chloroquine Phosphate in the Treatment of Novel Coronavirus Pneumonia

Status unknown Phase 2, PHASE3 Last updated 24 March 2020

What this trial tests

Phase 2, PHASE3 trial testing favipiravir tablets+chloroquine phosphatetablets tablets in Novel Coronavirus Pnuemonia in 150 participants. Status unknown.

Timeline

5 March 2020

Primary endpoint
30 April 2020

25 June 2020

Quick facts

Lead sponsor	Beijing Chao Yang Hospital
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	5 March 2020
Primary completion	30 April 2020
Estimated completion	25 June 2020
Sites	1 location across China

Drugs / interventions tested

• favipiravir tablets+chloroquine phosphatetablets tablets — full drug profile →
• Favipiravir tablets — full drug profile →
• Placebo

Conditions studied

• Novel Coronavirus Pnuemonia — all drugs for Novel Coronavirus Pnuemonia →

Sponsor

Beijing Chao Yang Hospital

Who can join

Adults 18 to 75, any sex, with Novel Coronavirus Pnuemonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a multi-centered, three-armed, randomized, double-blinded, controlled study, namely, the oral trial drug favipiravir tablets plus chloroquine phosphatetablets tablets group (combined group), the oral trial drug favipiravir tablets group (pirovir group), and the oral placebo treatment group (control group). The total number of enrolled cases in this study was set at 150.

During the treatment, the clinical data of the subjects were collected, the changes of viral load and biochemical indicators were detected, and the outcome of the subjects was monitored.

The main indicators of efficacy include improvement or recovery of respiratory symptoms and viral nucleic acid shedding. The rate of progression to severe disease, duration of fever, peripheral blood index and improvement time of pulmonary imaging were the secondary indicators to evaluate the efficacy.

Statistical analysis was performed at the middle and final stages of the study to evaluate the efficacy and safety of favipiravir tablets combined with chloroquine phosphatetablets tablets in the treatment of novel coronavirus pneumonia.

Publications & conference data

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

1. An Update on Current Therapeutic Drugs Treating COVID-19.
   Wu R, Wang L, Kuo HD, Shannar A, et al · · 2020 · cited 343× · PMID 32395418 · DOI 10.1007/s40495-020-00216-7
2. Role of favipiravir in the treatment of COVID-19.
   Joshi S, Parkar J, Ansari A, Vora A, et al · · 2021 · cited 244× · PMID 33130203 · DOI 10.1016/j.ijid.2020.10.069
3. COVID-19 and Cancer: a Comprehensive Review.
   Gosain R, Abdou Y, Singh A, Rana N, et al · · 2020 · cited 187× · PMID 32385672 · DOI 10.1007/s11912-020-00934-7
4. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
5. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics.
   Arshad U, Pertinez H, Box H, Tatham L, et al · · 2020 · cited 115× · PMID 32438446 · DOI 10.1002/cpt.1909
6. Comprehensive analysis of drugs to treat SARS‑CoV‑2 infection: Mechanistic insights into current COVID‑19 therapies (Review).
   Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, et al · · 2020 · cited 93× · PMID 32468014 · DOI 10.3892/ijmm.2020.4608
7. Therapeutic use of chloroquine and hydroxychloroquine in COVID-19 and other viral infections: A narrative review.
   Hashem AM, Alghamdi BS, Algaissi AA, Alshehri FS, et al · · 2020 · cited 85× · PMID 32387694 · DOI 10.1016/j.tmaid.2020.101735
8. Treatment Guidance for Patients With Lung Cancer During the Coronavirus 2019 Pandemic.
   Dingemans AC, Soo RA, Jazieh AR, Rice SJ, et al · · 2020 · cited 74× · PMID 32422364 · DOI 10.1016/j.jtho.2020.05.001