NCT04530474

Outpatient Use of Ivermectin in COVID-19

Withdrawn Phase 3 Last updated 26 May 2021

What this trial tests

Phase 3 trial testing Ivermectin Pill in Covid19. Withdrawn.

Timeline

1 April 2021

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Temple University
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	1 April 2021
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Ivermectin Pill — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Temple University

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Covid 19, a novel coronavirus, causes infection that, while mild to moderate in many people, can lead to severe disease in a significant portion. Currently, it is expected that the majority, 81%, of patients with COVID-19 will have mild to moderate disease, with 14% having more severe disease (2). There exists a number of candidate drugs that may inhibit SARS-CoV-2 infection or progression of disease. Simple, safe and low-cost strategies that may be the best solution to inhibit infection and limit transmission and spread of infection.

Ivermectin is a drug initially synthesized and used as an anthelmintic. It has been found to have activity against several RNA viruses such as the SARS-CoV-2 by mechanisms that inhibit importin α/β-mediated nuclear transport that may prevent viral proteins from entering the nucleus to alter host cell function. A recent in vitro study showed that a single dose of ivermectin could kill COVID-19 in vitro within 48 hours. A recent multi-continent retrospective study of 1,400 patients demonstrated an association of ivermectin use with lower in-hospital mortality 1.4% versus 8.5%. Given these findings and its safety profile, cost and ease of administration, Ivermectin warrants study as a potential treatment to prevent progression of COVID 19 infection.

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. Ivermectin for preventing and treating COVID-19.
   Popp M, Stegemann M, Metzendorf MI, Gould S, et al · · 2021 · cited 102× · PMID 34318930 · DOI 10.1002/14651858.cd015017.pub2
3. 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
4. Ivermectin as a potential drug for treatment of COVID-19: an in-sync review with clinical and computational attributes.
   Kaur H, Shekhar N, Sharma S, Sarma P, et al · · 2021 · cited 52× · PMID 33389725 · DOI 10.1007/s43440-020-00195-y
5. Ivermectin as a Broad-Spectrum Host-Directed Antiviral: The Real Deal?
   Jans DA, Wagstaff KM. · · 2020 · cited 52× · PMID 32942671 · DOI 10.3390/cells9092100
6. Ivermectin for preventing and treating COVID-19.
   Popp M, Reis S, Schießer S, Hausinger RI, et al · · 2022 · cited 30× · PMID 35726131 · DOI 10.1002/14651858.cd015017.pub3
7. Chemotherapy vs. Immunotherapy in combating nCOVID19: An update.
   Choudhury A, Mukherjee G, Mukherjee S. · · 2021 · cited 28× · PMID 34020832 · DOI 10.1016/j.humimm.2021.05.001
8. The broad spectrum host-directed agent ivermectin as an antiviral for SARS-CoV-2 ?
   Jans DA, Wagstaff KM. · · 2021 · cited 26× · PMID 33341233 · DOI 10.1016/j.bbrc.2020.10.042