Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With COVID-19 Infection.

NCT04407130 | Completed Phase 2 DMC

• 1 other identifier: PR-20039
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Burden: Initial outbreak of corona virus disease 2019 (COVID-19) was reported from Wuhan, China in early December 2019.Presently known to be caused by a novel beta-corona virus, named as Severe acute respiratory syndrome corona virus 2 ( SARS-CoV-2). World Health Organization (WHO) declared a pandemic on March. The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnoea and pneumonia Infected individuals exhibit:

1. 1.Mostly mild illness (80% +) recover without any treatment (\~80%)
2. 2.Moderate illness that needs hospitalization and recovers after standard
3. 3.supportive treatment (\~14%)
4. 4.Critical illness (\~5%) needs ICU support
5. 5.Death (1-2% )

Conditions

COVID-19 Patients

Outcome Measures

Primary Outcomes (3)

• Virological clearance

  • Presence of virus will be negative on Day 7 detected by RT PCR

  within 7 days after enrollment

• Remission of fever

  • Body temperature will be \< 37.5 C by day 7 detected by Infrared thermometer

  within 7 days after enrollment

• Remission of cough

  • Remission of cough: No signs of cough showing respiratory rate within 12-20/ min, on day7

  within 7 days after enrollment

Secondary Outcomes (5)

• Patients requiring oxygen

  within 7 days after enrollment

• Patients failing to maintain SpO2 >93% despite oxygenation

  within 7 days after enrollment

• Number of days on oxygen support

  within 7 days after enrollment

• Duration of hospitalization

  within 14 days after enrollment

• All causes of mortality

  within 14 days after enrollment

Study Arms (3)

Tab Ivermectin +Cap Doxycycline

ACTIVE COMPARATOR

200 mcg/kg (12 mg tablet) ivermectin (IVERA) single dose and 200 mg stat doxycycline day-1 followed by 100mg doxycycline 12hrly for 4 day (i.e. day2-day5) \+ Placebo one tablet D2-5

Drug: Ivermectin + Doxycycline + Placebo

Tab Ivermectin

ACTIVE COMPARATOR

Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5 \+ Placebo two tablets D1 followed by Placebo one tablet D2-5

Drug: Ivermectin + Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo 3 Placebo tablets D1 followed by 2 tablets D2-5

Drug: Placebo

Interventions

Ivermectin + Doxycycline + Placebo DRUG

Arm I: 200 mcg/kg (12 mg tablet) ivermectin (IVERA) single dose and 200 mg stat doxycycline day-1 followed by 100mg doxycycline 12hrly for 4 day (i.e. day2-day5) Placebo one tablet D2-5

Also known as: Tab IVERA +Cap Doxycycline

Tab Ivermectin +Cap Doxycycline

Ivermectin + Placebo DRUG

Arm II: Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5 + Placebo two tablets D1 followed by Placebo one tablet D2-5

Also known as: Tab IVERA

Tab Ivermectin

Placebo DRUG

Arm III: 3 Placebo tablets D1 followed by 2 tablets D2-5

Also known as: Tab Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Allergy to ivermectin or doxycycline; or other contraindications to any of the study medications
• History of chronic heart disease (IHD, heart failure, documented cardiomyopathy etc)
• History of chronic liver disease (SGPT value more than 3 times of normal value)
• History of chronic kidney disease (S. Creatinine for male \>1.3 mg/dL or \>115 µmol/L and for female \>1.2 mg/dL or \>106.1 µmol/L)
• Pregnant or lactating women
• Participated in any other clinical trial within last 4 weeks
• H/o received Ivermectin/Doxycycline within last 7 days

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Icddr,B

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Interventions

Ivermectin; Doxycycline

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Wasif Ali Khan, MBBS, MHS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Trial

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 29, 2020
• Study Start: June 16, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 20, 2020
• Last Updated: February 4, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)