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Hydroxychloroquine and Ivermectin for the Treatment of COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04391127
Recruitment Status : Completed
First Posted : May 18, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Centenario Hospital Miguel Hidalgo

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Hydroxychloroquine Drug: Ivermectin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description:

Two non-transparent bottles The first bottle will contain the initial treatment: Two ivermectin tablets, two hydroxychloroquine tablets, or two placebo tablets.

The second bottle will contain the follow-up treatment (10 tablets): Two tablets will be indicated, which will be take 12 hours after ingestion of the initial bottle and then one tablet every 12 hours for 4 more days. This bottle will contain placebo and hydroxychloroquine according to the corresponding group.

Primary Purpose: Treatment
Official Title: Efficacy and Safety of Hydroxychloroquine and Ivermectin in Hospitalized no Critical Patients Secondary to COVID-19 Infection: Randomized Controlled Trial
Actual Study Start Date : May 4, 2020
Actual Primary Completion Date : November 6, 2020
Actual Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hospitalized patients with COVID-19 QTc < 500 mseg
Patients with confirmed COVID-19 infection by RT-qPCR SARS-CoV-2 or suspected by chest computed tomography with criteria of hospitalization because emergency medical criteria, with no need of critical care assistance. The risk of hydroxychloroquine complications will be assessed by QT corrected by Bazett formula. If QTc < 500 ms could be randomized to hydroxychloroquine, ivermectin or placebo.
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.

Experimental: Hospitalized patients with COVID-19 infection with QTc >500ms
Patients with confirmed COVID-19 infection by RT-qPCR SARS-CoV-2 or suspected by chest computed tomography with criteria of hospitalization because emergency medical criteria, with no need of critical care assistance. The risk of hydroxychloroquine complications will be assessed by QT corrected by Bazett formula. If QTc > 500 ms could be randomized to ivermectin or placebo.
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.




Primary Outcome Measures :
  1. Mean days of hospital stay [ Time Frame: Three months ]
    Days from admission as a suspected case of COVID with hospitalization criteria until discharge

  2. Rate of Respiratory deterioration, requirement of invasive mechanical ventilation or dead [ Time Frame: Three months ]
    Respiratory deterioration defined by respiratory rate > 25 per minute, requirement of high oxygen supply (FiO2 > 80% ) to maintain oxygen saturation > 90 %, invasive mechanical ventilation or dead.

  3. Mean of oxygenation index delta [ Time Frame: Three months ]
    Daily delta of oxygenation index during the hospitalization


Secondary Outcome Measures :
  1. Mean time to viral PCR negativization [ Time Frame: 5, 14, 21 and 28 days after the first positive PCR ]
    Mean time to viral negativization of RT-qPCR SARS-CoV-2. Pre Specified time: 5, 14, 21 and 28 days after the first positive PCR.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RT-qPCR SARS-CoV-2 positivity or chest computed Tomography with suspected COVID-19 pneumonia
  • Hospitalization by medical emergency staff criteria

Exclusion Criteria:

  • Other confirmed viral active and acute infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391127


Locations
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Mexico
Jose Manuel Arreola Guerra
Aguascalientes, Mexico, 20259
Sponsors and Collaborators
Centenario Hospital Miguel Hidalgo
Additional Information:
Publications:

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Responsible Party: Centenario Hospital Miguel Hidalgo
ClinicalTrials.gov Identifier: NCT04391127    
Other Study ID Numbers: 2020-A-09
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Hydroxychloroquine
Ivermectin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents