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Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With 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: NCT04407130
Recruitment Status : Enrolling by invitation
First Posted : May 29, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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

COVID-19 has now spread >210 countries and territories globally. SARS-CoV-2 is a respiratory virus which spreads primarily through droplets generalized when an infected person coughs or sneezes or through droplets of saliva or discharge from the nose.

Symptomatic management remains the mainstay of treatment strategy. Mortality appears to be more common in older individuals and those with co-morbidities, such as chronic lung disease, cardiovascular disease and diabetes. Young people with no comorbidities also appear to be at risk for critical illness including multi-organ failure and death. Seen more in Bangladesh between 21-40 yrs of age.

Knowledge Gap:

There is no specific treatment against this new virus that WHO has officially declared until now.There are many pharmacologic therapies that are being used or considered for treatment of COVID-19. National Guidelines on Clinical Management of Corona virus Disease 2019 (Covid-19): V 5.0 date 9th April 2020) CDC, DGHS, GoB

Thus an RCT is urgently needed in Bangladesh: Based on recent literatures on Rx studies in COVID-19 patients from other countries as well as its availability & affordability of those repurposed medicines


Condition or disease Intervention/treatment Phase
COVID-19 Patients Drug: Ivermectin + Doxycycline + Placebo Drug: Ivermectin + Placebo Drug: Placebo Phase 2

Detailed Description:

Objectives:

General Objective:

The aim of the study is to evaluate efficacy and safety of ivermectin in combination with doxycycline or ivermectin alone for the treatment of hospitalized SARS-CoV-2 infected adult Bangladeshi COVID-19 +ve patients and to compare with placebo; where all three arms will receive the standard care of treatment of COVID-19 infected patients in the hospital. By successful demonstration of the safety and efficacy of these repurposed medicines, it may have the potential to play an important role in the treatment of COVID-19+ve patients.

Specific Objective:

  1. Duration of the virological clearance rate
  2. Days required for remission of fever and cough

Secondary Objective:

  • Patients requiring oxygen
  • Patients failing to maintain SpO2 >88 despite oxygenation
  • Number of days on oxygen support
  • Chest X-ray improvement
  • Duration of hospitalization
  • All cause mortality

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled Trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ivermectin and Doxycycline in Combination or Ivermectin Alone for the Treatment of Adult Bangladeshi Patients Hospitalized for COVID-19: a Randomised, Double-blind, Placebo-controlled Trial.
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tab Ivermectin +Cap Doxycycline

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

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

Other Name: Tab IVERA +Cap Doxycycline

Active Comparator: Tab Ivermectin

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
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
Other Name: Tab IVERA

Placebo Comparator: Placebo

Drug: Placebo

3 Placebo tablets D1 followed by 2 tablets D2-5

Drug: Placebo
Arm III: 3 Placebo tablets D1 followed by 2 tablets D2-5
Other Name: Tab Placebo




Primary Outcome Measures :
  1. Virological clearance [ Time Frame: within 7 days after enrollment ]
    • Presence of virus will be negative on Day 7 detected by RT PCR

  2. Remission of fever [ Time Frame: within 7 days after enrollment ]
    • Body temperature will be between 36.1 to 37.2 C by day 7 detected by Infrared thermometer

  3. Remission of cough [ Time Frame: within 7 days after enrollment ]
    • Remission of cough: No signs of cough showing respiratory rate within 12-20/ min, on day7


Secondary Outcome Measures :
  1. Patients requiring oxygen [ Time Frame: within 7 days after enrollment ]
    Detected SPO2 level <94% on Day 7or before by pulse oxymeter

  2. Patients failing to maintain SpO2 >88% despite oxygenation [ Time Frame: within 7 days after enrollment ]
    Patients who fail to maintain pulse oxymeter detected SpO2 level>88% despite O2 supplementation of 2-6L/min, on Day 7 or before

  3. Number of days on oxygen support [ Time Frame: within 7 days after enrollment ]
    Any number of days on oxygen support on Day 7 or before recorded in CRF

  4. Chest X-ray improvement [ Time Frame: within 7 days after enrollment ]
    CXR showing decreases lung opacity or consolidation on day 7 compared with enrollment day

  5. Duration of hospitalization [ Time Frame: within 14 days after enrollment ]
    Hospital stay ≥7days to ≤14 days as per CRF records

  6. All causes of mortality [ Time Frame: within 14 days after enrollment ]
    Death any time during 14 days of study period from any cause recorded in CRF and Hospital death certificate



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criterion:

  • Bangladeshi aged 40-65 years admitted to any of the aforementioned study sites (hospitals)
  • Either sex
  • At the enrollment having at least one of the following symptoms: Temp 37.5 C or above, Cough, Sore throat
  • SpO2 >94%
  • Duration of illness ≤ 7 days
  • No oxygen support on enrollment
  • Capable of swallowing oral medication
  • PCR positive for SARS-CoV2 virus
  • The participant properly informed about the study and agreed to sign the informed consent form (ICF)

Exclusion Criteria:

  • 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
  • Already received Ivermectin / Doxycycline before hospitalization

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): NCT04407130


Locations
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Bangladesh
Icddr,B
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Wasif Ali Khan, MBBS, MHS International Centre for Diarrhoeal Disease Research, Bangladesh
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT04407130    
Other Study ID Numbers: PR-20039
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 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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Doxycycline
Ivermectin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents