NCT04438850: COVER

COVidIVERmectin: Ivermectin for Treatment of Covid-19

Terminated Phase 2 Last updated 23 June 2021

What this trial tests

Phase 2 trial testing Ivermectin in Covid19 in 93 participants. Terminated before completion.

Timeline

31 July 2020

Primary endpoint
8 June 2021

8 June 2021

Quick facts

Lead sponsor	IRCCS Sacro Cuore Don Calabria di Negrar
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	93
Start date	31 July 2020
Primary completion	8 June 2021
Estimated completion	8 June 2021
Sites	5 locations across Italy

Drugs / interventions tested

• Ivermectin (ivermectin) — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar — full company profile →

Who can join

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

Sponsor's own description

Prospective, multi-centre, randomized, double-blind trial to assess efficacy and safety of ivermectin for the treatment of initial infection with SARS-CoV2 infection.

Study arms: A) placebo B) ivermectin 600 μg/kg daily for 5 consecutive days (I\_600) + placebo. C) ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days (I\_1200). Patients will be randomized at emergency room of hospitals as well as at outpatient ambulatory care as well as at home, according to routine procedures of recruiting centres.

In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.

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. Identification of 3-chymotrypsin like protease (3CLPro) inhibitors as potential anti-SARS-CoV-2 agents.
   Mody V, Ho J, Wills S, Mawri A, et al · · 2021 · cited 171× · PMID 33473151 · DOI 10.1038/s42003-020-01577-x
3. 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
4. Druggable targets of SARS-CoV-2 and treatment opportunities for COVID-19.
   Faheem, Kumar BK, Sekhar KVGC, Kunjiappan S, et al · · 2020 · cited 62× · PMID 32947136 · DOI 10.1016/j.bioorg.2020.104269
5. 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
6. Ivermectin as a Broad-Spectrum Host-Directed Antiviral: The Real Deal?
   Jans DA, Wagstaff KM. · · 2020 · cited 52× · PMID 32942671 · DOI 10.3390/cells9092100
7. 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
8. 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