Randomized Phase IIA Clinical Trial to Evaluate the Efficacy of Ivermectin to Obtain Negative PCR Results in Patients With Early Phase COVID-19
Condition: Covid19; Coronavirus Infection; SARS-CoV Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      SAINT-PERU is a triple-blinded, randomized placebo-controlled trial with two parallel arms to
      evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with
      SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.
    

Detailed description: 
      SAINT is a triple-blinded, randomized placebo-controlled trial with two parallel arms to
      evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with
      SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.

      The planned sample size is 186 SARS-CoV-2 PCR positive patients: 93 patients to treatment and
      93 to the placebo group. Participants will be randomized to receive one dose of 300 mcg/kg
      ivermectin or placebo daily for three consecutive days. The epidemiologist will generate a
      list of correlative numbers, in randomized blocks of size 4, with the assignment to the
      treatment groups (a and b). The randomization list will be kept in an encrypted file
      accessible only to the trial statistician. This list will be handed directly to the
      pharmacist. Independently, the principal investigator will randomly assign the intervention
      (ivermectin) to one of the two groups (a or b) by tossing a coin, and will inform the
      pharmacist of the result of this process. The pharmacist will prepare and label the treatment
      vials according to the randomization list prepared by the epidemiologist and the treatment
      assignment given by the principal investigator. Eligible patients will be allocated in a 1:1
      ratio using this randomization list.

      Participants are expected to remain in the trial for a period of 21 days.

      In the interests of public health and containing transmission of infection, follow-up visits
      will be conducted by the trial medical staff at the participant's home or at a hospital in
      case of hospitalization.

      Follow-up visits will assess clinical and laboratory parameters of the patients.
    

Intervention name(s): Ivermectin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One daily dose of NOXAL-Ivermectin Oral Solution (6 mg/mL) at 300mcg/kg for three (3) consecutive days. A weight-equivalence table will be used to determine each participant´s dose (number of oral drops/day).; The placebo presentation will be an oral drop solution undistinguishable from ivermectin, but without this device pharmaceutical ingredient.
Other intervention name(s): Noxal
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SAINT-PERU is a triple-blinded, randomized, placebo-controlled trial with two parallel arms to evaluate the efficacy of one daily dose of ivermectin during three consecutive days, administered to patients with a positive PCR test for SARS-CoV-2 in a nasopharyngeal specimen, symptomatic for 96 hours or less, with non-severe COVID-19 disease at baseline, regardless of the presence of risk factors for progression to severity. The efficacy of the drug-based strategy to reduce or block transmission involves treating during early phases of infection, when viral replication is yet limited.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment