Hydroxychloroquine and Ivermectin for the Treatment of COVID-19 Infection

Summary

Background: In December 2019, patients with pneumonia secondary to a new subtype of Coronavirus (COVID-19) were identified in China. In a few weeks the virus spread and cases started practically all over the world. In February 2020, the WHO declared a pandemic. Severe symptoms have been found in patients mainly with comorbidities and over 50 years of age. At this time there is no proven therapeutic alternative. In vitro studies and observational experiences showed that antimalarial drugs (Chloroquine and hydroxychloroquine) had antiviral activity and increased viral clearance. Ivermectin, on the other hand, has been shown in vitro to reduce viral replication and in an observational cohort, greater viral clearance with promising clinical results. So far there is no standard of treatment and clinical trials are needed to find effective treatment alternatives. Objective: To evaluate the safety and efficacy of treatment with hydroxychloroquine and ivermectin for serious COVID-19 infections in no critical hospitalized patients. Material and methods: Randomized controlled trial of patients diagnosed with respiratory infection by COVID-19, who present criteria for hospitalization. Randomization will be performed to receive hydroxychloroquine at a dose of 400 mg every 12 hours for one day and then 200 mg every 12 hours, to complete a 5-day treatment schedule. Group 2: Ivermectin 12 mg every 24 hours for one day (less than 80 kg) or Ivermectin 18 mg every 24 hours for one day (greater than 80 kg) + placebo until the fifth day. Group 3: Placebo. Prior to randomization, the risk of cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake will be assessed. If the patient is at high risk, the allocation will be to ivermectin only or to placebo in an independent randomization, if the risk is low, any of the three groups could be assigned. Outcomes: The primary outcome will be discharge from hospital for improvement. The safety outcomes will be requirement of mechanical intubation, septic shock or death. Viral clearance will also be evaluated by means of PCR, which will be taken on the 5th day after admission, day 14 and 21.

Conditions

• COVID-19

Interventions

DRUG

Hydroxychloroquine

Hydroxychloroquine: 400 mg PO every 12 hours for one day. Subsequently 200 mg every 12 hours per 4 more days.

DRUG

Ivermectin

Ivermectin 12 mg PO every 24 hours for one day (in case of weight less than 80 kg) or 18 mg PO every 24 hours for one day (in case of weight over 80 kg) Subsequently this group will take two tablets of placebo 12 hrs after ivermectin ingestion and then one tablet of placebo each 12 hrs per 4 more days.

DRUG

Placebo

Two tablets of placebo PO every 12 hours for one day. Subsequently one tablet of placebo every 12 hours per 4 more days.

Sponsors & Collaborators

• Centenario Hospital Miguel Hidalgo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-04

Primary Completion

2020-11-06

Completion

2020-11-06

Countries

• Mexico

Study Locations