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Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed 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: NCT04523831
Recruitment Status : Completed
First Posted : August 24, 2020
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Reaz Mahmud, Dhaka Medical College

Brief Summary:

On 31 December 2019, the World Health Organization (WHO) was formally notified about a cluster of cases of pneumonia in Wuhan City, China. On 7 January the responsible virus was isolated and its genome sequence was shared on 12 January. It was named as COVID-19, a novel Coronavirus, SARS-CoV-2. It is a member of the Corona virus family which is RNA enveloped viruses.

Very rapidly the virus emerged as pandemic. Now it is dominating the lives of every people of this universe. Management of the COVID-19 relies on mainly supportive care and oxygen supplementation via non-invasive or mechanical ventilation in critical cases. Patients who are critically ill may also require vasopressor support and antibiotics for secondary bacterial infections.

There is no vaccine or highly effective antiviral drugs for COVID-19. Currently there is a tremendous effort around the world to develop effective preventive and therapeutic treatment for this disease.

World Health Organization has launched a non-blinded clinical trial (SOLIDARITY) to evaluate four candidate treatments (remdesivir, lopinavir/ritonavir, lopinavir/ritonavir/ interferon beta-1a, and chloroquine or hydroxychloroquine) versus standard of care in 18 countries worldwide. RECOVERY trial one of the largest trials to see the efficacy and safety of hydroxychloroquine revealed that they are no clear cut clinical benefit for COVID-19. Other drugs in the SOLIDARTY trial are quite expansive for resource limited countries like Bangladesh.

Study Published in the American Journal of Tropical Medicine advocates further research into Ivermectin for COVID-19 Treatment. The spotlight on Ivermectin was brought by Australian researchers from Monash University who demonstrated its efficacy against the SARS-CoV-2 coronavirus in vitro studies.

In different study Doxycycline also showed promising results in treatment of COVID 19 infection. It is highly lipophilic antibiotics that are known to chelate zinc component of matrix metalloprotienases (MMP). Corona viruses are known to rely heavily of MMPs for survival, cell infiltration and replication. It also has an anti-inflammatory effect which might be effective in combating cytokine storm of Covid-19 infection.

So it have been planned to conduct an experimental clinical trial using combination of ivermectin and doxycycline for treatment of COVID 19 along with the other standard care.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Ivermectin and Doxycycline Drug: Standard of care Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patient will be randomized 1:1 to placaebo with standard care and combined doxycycline and ivermectin with standard care.
Masking: Double (Participant, Investigator)
Masking Description: Double blind (The participant and the clinicians/data collectors will be unaware of the treatment the participant receives).The drugs will be labelled with a random code number
Primary Purpose: Treatment
Official Title: A Phase III Trial to Promote Recovery From Covid 19 With Combined Doxycycline and Ivermectin Along Standard Care
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : August 22, 2020
Actual Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ivermectin and Doxycycline
Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5 days
Drug: Ivermectin and Doxycycline
Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days
Other Name: Imac and Doxibac

Drug: Standard of care
Paracetamol, Vitamin D, Oxygen if indicated, Low molecular weight heparin, dexamethasone if indicated

Placebo Comparator: Placebo
Standard treatment
Drug: Standard of care
Paracetamol, Vitamin D, Oxygen if indicated, Low molecular weight heparin, dexamethasone if indicated




Primary Outcome Measures :
  1. Number of Patients With Early Clinical Improvement [ Time Frame: 7 days ]

    Number of patients have clinical improvement as described by WHO and Bangladesh local guideline with 7 days..

    1. Body temperature remains normal for at least 3 days (ear temperature is lower than 37.5 °C).
    2. Respiratory symptoms are significantly improved.
    3. Lung imaging shows obvious improvement in lesions.
    4. There is no co-morbidities or complications which require hospitalization.
    5. SpO2, >93% without assisted oxygen inhalation.

  2. Number of Participants With Late Clinical Recovery [ Time Frame: 12 days ]
    Number of the patients required more than 12 days for clinical improvement as defined above.


Secondary Outcome Measures :
  1. Number of Patients Having Clinical Deterioration. [ Time Frame: 1 month ]

    Number of patients deteriorating to next level of severity, like moderate, severe and death. That is from mild illness at presentation with subsequent follow up developed moderate, severe illness or death. Like wise from moderate illness at presentation developed severe illness or death.

    Mild illness: These patients usually present with symptoms of an upper respiratory tract viral infection, including mild fever, cough (dry), sore throat, nasal congestion, malaise, headache, muscle pain, or malaise. Signs and symptoms of a more serious disease, such as dyspnea, are not present Moderate illness: Respiratory symptoms such as cough and shortness of breath (or tachypnea in children) are present without signs of severe pneumonia.

    Severe illness:severe dyspnea, respiratory distress, tachypnea (> 30 breaths/min), and hypoxia (SpO2 < 90% on room air).


  2. Number of Patients Remain Persistently Positive for RT-PCR of Covid-19 [ Time Frame: 14 days ]
    Number of Patients remain positive for RT-PCR of Covid-19 at day 14 after the day of initial positivity.



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 infection, confirmed by polymerase chain reaction (PCR) test within 3 days from enrollment
  • Only mild and moderate COVID-19 infected cases
  • Able to provide informed consent

Exclusion Criteria:

  • Unable to take oral medication
  • Pregnant or breast feeding lady
  • Patients with severe COVID symptoms or admission in ICU/HDU
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 upper limit of normal (ULN)
  • On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
  • Known hypersensitivity to Doxycycline or ivermectin or its components.

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): NCT04523831


Locations
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Bangladesh
Dhaka Medical College
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
Dhaka Medical College
Investigators
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Principal Investigator: Mahmud Reaz, FCPS Assistant Professor
  Study Documents (Full-Text)

Documents provided by Dr. Reaz Mahmud, Dhaka Medical College:
Statistical Analysis Plan  [PDF] August 26, 2020

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Responsible Party: Dr. Reaz Mahmud, Assistant Professor, Dhaka Medical College
ClinicalTrials.gov Identifier: NCT04523831    
Other Study ID Numbers: ERC-DMC/ECC/2020/117
First Posted: August 24, 2020    Key Record Dates
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patients age, sex, Date of covid positive report, Symtoms,Date of covid negative report, post covid symptoms, time to recover.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: September 2020 to December 2020
Access Criteria: Person who are investigating covid-19 in various aspects

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Reaz Mahmud, Dhaka Medical College:
Covid-19, Ivermectin
Additional relevant MeSH terms:
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Doxycycline
Ivermectin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents