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NCT Number: NCT04591600

Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients

A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Akarkh Healt hdirectorate

Baghdad, 14222, Iraq

About this study

Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID-19 patients at any stage of this disease

Exclusion criteria

  • Patients of allergic history to Ivermectin or to doxycyline

Treatment and study plan

Ivermectin and Doxycyline

Drug

Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.

Other names: Stromectol and Doxycin

Standard of care

Drug

Standard care

  • Acetaminophen 500mg on need
  • Vitamin C 1000mg twice/ day
  • Zinc 75-125 mg/day
  • Vitamin D3 5000IU/day
  • Azithromycin 250mg/day for 5 days
  • Oxygen therapy/ C-Pap if needed
  • dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
  • Mechanical ventilation, if needed

Other names: Control arm

Primary outcomes

  1. Mortality rate

    Time frame: Up to 8 weeks

    The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients

  2. Rate of progression disease

    Time frame: up to 8 weeks

    rate of patients under treatment who undergo progression of disease to a more advanced stage

Secondary outcomes

  1. Time to recovery

    Time frame: Up to 8 weeks

    time needed by treated patients to recover (become symptoms free and polymerase chain reaction, or PCR, negative)

Sponsors and collaborators

Lead sponsor

Alkarkh Health Directorate-Baghdad

Other Gov

Registry information

Official study title

Controlled Randomized Clinical Trial on Using Ivermectin With Doxycycline for Treating COVID-19 Patients in Baghdad, Iraq

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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