NCT04530422

Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment

Completed Phase 3 Last updated 28 August 2020

What this trial tests

Phase 3 trial testing Sofosbuvir plus Ledipasvir in Covid19 in 250 participants. Completed in 23 July 2020.

Timeline

15 April 2020

Primary endpoint
8 July 2020

23 July 2020

Quick facts

Lead sponsor	Almaza Military Fever Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	250
Start date	15 April 2020
Primary completion	8 July 2020
Estimated completion	23 July 2020
Sites	1 location across Egypt

Drugs / interventions tested

• Sofosbuvir plus Ledipasvir — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Almaza Military Fever Hospital

Who can join

Adults 18 to 75, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Currently there is no known effective therapy or vaccine for treatment of SARS-CoV-2, highlighting urgency around identifying effective therapies.

This study aiming to evaluate the anti-HCV medications efficacy "Sofosbuvir-Ledipasvir" in treatment of moderate cases with SARS-COV-2 infection, in comparison to the standard treatment (hydroxychloroquine, oseltamivir and azithromycin).

Publications & conference data

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

1. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
2. 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
3. SARS-CoV-2 RNA-dependent RNA polymerase as a therapeutic target for COVID-19.
   Vicenti I, Zazzi M, Saladini F. · · 2021 · cited 77× · PMID 33475441 · DOI 10.1080/13543776.2021.1880568
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. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
6. Targeting SARS-CoV-2 viral proteases as a therapeutic strategy to treat COVID-19.
   Anirudhan V, Lee H, Cheng H, Cooper L, et al · · 2021 · cited 47× · PMID 33475167 · DOI 10.1002/jmv.26814
7. Strategy, Progress, and Challenges of Drug Repurposing for Efficient Antiviral Discovery.
   Li X, Peng T. · · 2021 · cited 25× · PMID 34017257 · DOI 10.3389/fphar.2021.660710
8. Progress and pitfalls of a year of drug repurposing screens against COVID-19.
   Sourimant J, Aggarwal M, Plemper RK. · · 2021 · cited 23× · PMID 34218010 · DOI 10.1016/j.coviro.2021.06.004