AzTrials
AzTrials

COVID-19 PatientsPhase 2NCT04407130

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

A Phase 2 study of COVID-19 Patients, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
COVID-19 Patients
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteBangladesh
Study dates
16 Jun 2020to 20 Nov 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Bangladeshi aged 18-65 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Icddr,B

    Dhaka, 1000

Other trials in Bangladesh

About this study

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.

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).

Read more

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

Read the 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
Being tested
Ivermectin + Doxycycline + Placebo, Ivermectin + Placebo, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ivermectin + Doxycycline + PlaceboDrug

    Also called Tab IVERA +Cap Doxycycline

    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

  • Ivermectin + PlaceboDrug

    Also called Tab IVERA

    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

  • PlaceboDrug

    Also called Tab Placebo

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

Study groups in NCT04407130
Study groupRoleWhat they receive
Tab Ivermectin +Cap DoxycyclineActive comparator200 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
Receives: Drug: Ivermectin + Doxycycline + Placebo
Tab IvermectinActive comparatorIvermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5 + Placebo two tablets D1 followed by Placebo one tablet D2-5
Receives: Drug: Ivermectin + Placebo
PlaceboPlacebo comparatorDrug: Placebo 3 Placebo tablets D1 followed by 2 tablets D2-5
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Virological clearance

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

    Measured: within 7 days after enrollment

  2. Remission of fever

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

    Measured: within 7 days after enrollment

  3. Remission of cough

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

    Measured: within 7 days after enrollment

Secondary outcomes (5)

  1. Patients requiring oxygen

    Detected SPO2 level <94% on Day 7or before by pulse oxymeter

    Measured: within 7 days after enrollment

  2. Patients failing to maintain SpO2 >93% despite oxygenation

    Patients who fail to maintain pulse oxymeter detected SpO2 level>93% despite O2 supplementation of 2-6 L/min, on Day 7 or before

    Measured: within 7 days after enrollment

  3. Number of days on oxygen support

    Any number of days on oxygen support on Day 7 or before recorded in CRF

    Measured: within 7 days after enrollment

  4. Duration of hospitalization

    Hospital stay ≥7days to ≤14 days as per CRF records

    Measured: within 14 days after enrollment

  5. All causes of mortality

    Death any time during 14 days of study period from any cause recorded in CRF and Hospital death certificate

    Measured: within 14 days after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start16 Jun 2020
  3. Primary completion30 Oct 2020
  4. Study completion20 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled Trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407130
Sponsor's protocol ID
PR-20039
Status last verified
Jun 2020
First submitted
17 May 2020
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of COVID-19 Patients, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Virological clearance (time frame: within 7 days after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04407130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in