NCT04431466: IFORS

A Study to Compare the Efficacy and Safety of Different Doses of Ivermectin for COVID-19

Terminated Phase 2 Last updated 12 October 2021

What this trial tests

Phase 2 trial testing Ivermectin in Coronavirus Infection in 32 participants. Terminated before completion.

Timeline

1 July 2020

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	Universidade Federal de Sao Carlos
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 July 2020
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	2 locations across Brazil

Drugs / interventions tested

• Ivermectin (ivermectin) — full drug profile →
• Standard of Care

Conditions studied

• Coronavirus Infection — all drugs for Coronavirus Infection →

Sponsor

Universidade Federal de Sao Carlos

Who can join

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

Sponsor's own description

In December 2019, a group of patients with pneumonia of unknown cause was linked to a wholesale seafood market in Wuhan, China. The genetic analysis of samples from the lower respiratory tract of these patients indicated a new coronavirus as the causative agent, which was named SARS-CoV-2. The virus spread rapidly to more than 45 countries, including Brazil, causing an international alarm. However, in spite of its epidemiological magnitude, so far, there is no antiviral treatment or vaccine approved for the treatment of this infection. With about 15% to 20% of SARS-CoV-2 patients suffering from serious illnesses and overburdened hospitals, therapeutic options are desperately needed. So, instead of creating compounds from scratch that can take years to develop and test, researchers and public health agencies have sought to redirect drugs already approved for other diseases and known to be widely safe. In this context, the analysis of the international literature shows the existence of an in vitro antiviral activity of ivermectin against SARS-CoV-2. However, there are no studies that have evaluated its clinical effectiveness in patients diagnosed with SARS-CoV-2 infection. Therefore, and considering this knowledge gap, the present study aims to determine the clinical efficacy and safety of different doses of ivermectin in patients diagnosed with SARS-CoV-2 infection.

Publications & conference data

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

1. 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
2. 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
3. Ivermectin as a Broad-Spectrum Host-Directed Antiviral: The Real Deal?
   Jans DA, Wagstaff KM. · · 2020 · cited 52× · PMID 32942671 · DOI 10.3390/cells9092100
4. Ivermectin: an award-winning drug with expected antiviral activity against COVID-19.
   Formiga FR, Leblanc R, de Souza Rebouças J, Farias LP, et al · · 2021 · cited 48× · PMID 33038449 · DOI 10.1016/j.jconrel.2020.10.009
5. Therapeutics for COVID-19 and post COVID-19 complications: An update.
   Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
6. The recent outbreaks of human coronaviruses: A medicinal chemistry perspective.
   Pillaiyar T, Wendt LL, Manickam M, Easwaran M. · · 2021 · cited 32× · PMID 32852058 · DOI 10.1002/med.21724
7. 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
8. 2-Deoxy-D-Glucose and its Derivatives for the COVID-19 Treatment: An Update.
   Huang Z, Chavda VP, Vora LK, Gajjar N, et al · · 2022 · cited 29× · PMID 35496298 · DOI 10.3389/fphar.2022.899633