NCT04482686

Trial of Combination Therapy to Treat COVID-19 Infection

Completed Phase 1 Last updated 24 September 2024

What this trial tests

Phase 1 trial testing Ivermectin in COVID in 31 participants. Completed in 15 July 2022.

Timeline

9 December 2020

Primary endpoint
15 May 2022

15 July 2022

Quick facts

Lead sponsor	ProgenaBiome
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	31
Start date	9 December 2020
Primary completion	15 May 2022
Estimated completion	15 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Ivermectin (ivermectin) — full drug profile →
• Doxycycline Hcl
• Zinc — full drug profile →
• Vitamin D3 (cholecalciferol) — full drug profile →
• Vitamin C — full drug profile →

Conditions studied

• COVID — all drugs for COVID →
• Covid-19 — all drugs for Covid-19 →
• Corona Virus Infection — all drugs for Corona Virus Infection →
• Coronavirus Infection — all drugs for Coronavirus Infection →

Sponsor

ProgenaBiome — full company profile →

Who can join

18 and older, any sex, with COVID or Covid-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.

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. Zinc and COVID-19: Basis of Current Clinical Trials.
   Pal A, Squitti R, Picozza M, Pawar A, et al · · 2021 · cited 95× · PMID 33094446 · DOI 10.1007/s12011-020-02437-9
3. Vitamin D supplementation for the treatment of COVID-19: a living systematic review.
   Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, et al · · 2021 · cited 85× · PMID 34029377 · DOI 10.1002/14651858.cd015043
4. Antibiotics for the treatment of COVID-19.
   Popp M, Stegemann M, Riemer M, Metzendorf MI, et al · · 2021 · cited 60× · PMID 34679203 · DOI 10.1002/14651858.cd015025
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. Potential molecular mechanisms of zinc- and copper-mediated antiviral activity on COVID-19.
   Rani I, Goyal A, Bhatnagar M, Manhas S, et al · · 2021 · cited 43× · PMID 34284268 · DOI 10.1016/j.nutres.2021.05.008
8. 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