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NCT04373824

Max Ivermectin- COVID 19 Study Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study

Status unknown NA Last updated 4 May 2020
What this trial tests

NA trial testing Ivermectin in COVID in 50 participants. Status unknown.

Timeline
25 April 2020
Primary endpoint
25 July 2020
25 July 2020

Quick facts

Lead sponsorMax Healthcare Insititute Limited
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment50
Start date25 April 2020
Primary completion25 July 2020
Estimated completion25 July 2020
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Max Healthcare Insititute Limited

Who can join

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

Sponsor's own description

At present, there are no specific treatments for COVID-19. WHO recommends four treatments for COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir, Lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. Currently, there are several ongoing clinical trials evaluating potential treatments. Recently, LeonCaly reported that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to effect about 5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for possible benefits in humans. The study rationale is to understand the effect of the drug on eradication of virus.

Publications & conference data

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

  1. 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
  2. Ivermectin as a Broad-Spectrum Host-Directed Antiviral: The Real Deal?
    Jans DA, Wagstaff KM. · · 2020 · cited 52× · PMID 32942671 · DOI 10.3390/cells9092100
  3. 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
  4. Ivermectin: potential candidate for the treatment of Covid 19.
    Gupta D, Sahoo AK, Singh A. · · 2020 · cited 36× · PMID 32615072 · DOI 10.1016/j.bjid.2020.06.002
  5. 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
  6. 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
  7. COVID-19 associated complications and potential therapeutic targets.
    Monpara JD, Sodha SJ, Gupta PK. · · 2020 · cited 21× · PMID 32926918 · DOI 10.1016/j.ejphar.2020.173548
  8. Pharmacological insight into potential therapeutic agents for the deadly Covid-19 pandemic.
    Bhandari R, Khanna G, Kuhad A. · · 2021 · cited 13× · PMID 33065092 · DOI 10.1016/j.ejphar.2020.173643

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04373824.

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