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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Covid19
Interventions Drug: Ivermectin and Doxycycline
Drug: Standard of care
Enrollment 400
Recruitment Details The trial was designed to evaluate the effects of potential treatments in hospitalized and outdoor patients with mild to moderate COVID-19 infection, from 1 June to 30 august, 2020 in the largest COVID-19 dedicated hospital, Dhaka Medical College Hospital in Bangladesh.
Pre-assignment Details Of 556 patients who screened and were assessed for eligibility, 400 underwent randomization. Total 200 patients received active drug and 200 patient received placebo.
Arm/Group Title Ivermectin and Doxycycline Placebo
Hide Arm/Group Description

Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5 days

Ivermectin and Doxycycline: Ivermectin 6 mg stat and Doxycycline 100 mg twice daily for 5 days

 Standard treatment
Period Title: Overall Study
Started 200 200
Completed 183 180
Not Completed 17 20
Reason Not Completed
Lost to Follow-up             15             17
Death             0             3
Adverse Event             2             0
Arm/Group Title Ivermectin and Doxycycline Placebo Total
Hide Arm/Group Description

Ivermactin 6 mg 2 tab stat, cap Doxycycline 100 mg 1 cap BD 5 days

Ivermectin and Doxycycline: Ivermectin 6 mg stat and Doxycycline 100 mg twice daily for 5 days

 Standard treatment Total of all reporting groups
Overall Number of Baseline Participants 200 200 400
Hide Baseline Analysis Population Description
We followed intention to treat analysis; SPSS (Statistical Package for Social Sciences) version 20 was used to analyze data. To compare mean of the two group chi square test was done.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 200 participants 400 participants
40.72  (14.28) 38.47  (11.89) 39.59  (13.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 400 participants
Female
77
  38.5%
88
  44.0%
165
  41.3%
Male
123
  61.5%
112
  56.0%
235
  58.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Patients With Early Clinical Improvement
Hide Description

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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Linear logistic regression
Arm/Group Title Ivermectin Plus Doxycycline Placebo
Hide Arm/Group Description:
Ivermectin plus Doxycycline plus Standard of care
Placebo plus Standard of care
Overall Number of Participants Analyzed 183 180
Measure Type: Count of Participants
Unit of Measure: Participants
111
  60.7%
80
  44.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin Plus Doxycycline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.03
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.30 to 0.96
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Late Clinical Recovery
Hide Description Number of the patients required more than 12 days for clinical improvement as defined above.
Time Frame 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Binary logistic regression
Arm/Group Title Ivermectin Plus Doxycycline Placebo
Hide Arm/Group Description:
Ivermectin plus Doxycycline plus standard of care
Placebo plus standard of care
Overall Number of Participants Analyzed 183 180
Measure Type: Count of Participants
Unit of Measure: Participants
42
  23.0%
67
  37.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin Plus Doxycycline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.004
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.32 to 0.80
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Having Clinical Deterioration.
Hide Description

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).
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Binary Logistic regression
Arm/Group Title Ivermectin Plus Doxycycline Placebo
Hide Arm/Group Description:
Ivermection plus Doxycycline Plus standard of Care
Placebo plus standard of care
Overall Number of Participants Analyzed 183 180
Measure Type: Count of Participants
Unit of Measure: Participants
16
   8.7%
32
  17.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin Plus Doxycycline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.013
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.23 to 0.85
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients Remain Persistently Positive for RT-PCR of Covid-19
Hide Description Number of Patients remain positive for RT-PCR of Covid-19 at day 14 after the day of initial positivity.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Binary logistic regression
Arm/Group Title Ivermectin Plus Doxycycline Placebo
Hide Arm/Group Description:
Ivermectin plus Doxycycline plus standard of care
Placebo plus standard of care
Overall Number of Participants Analyzed 183 180
Measure Type: Count of Participants
Unit of Measure: Participants
14
   7.7%
36
  20.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ivermectin Plus Doxycycline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.44 to 0.81
Estimation Comments [Not Specified]
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ivermectin and Doxycycline Placebo
Hide Arm/Group Description Ivermectin Plus Doxycycline plus standard of care Placebo plus standard of care
All-Cause Mortality
Ivermectin and Doxycycline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   00/183 (0.00%)      03/180 (1.67%)    
Hide Serious Adverse Events
Ivermectin and Doxycycline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   02/183 (1.09%)      00/180 (0.00%)    
Gastrointestinal disorders     
Erosive esophagitis † 1  2/183 (1.09%)  2 0/180 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.8%
Ivermectin and Doxycycline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   07/183 (3.83%)      00/180 (0.00%)    
Gastrointestinal disorders     
Non ulcer Dyspepsia † 1  7/183 (3.83%)  7 0/180 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
†
Indicates events were collected by systematic assessment
We followed up the patients by telephonic (video) interview, which has some inherent drawback for the study. we could not assess viral clearance directly. Only single dose regimen was used. Efficacy might higher if the different regimen would use.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Reaz Mahmud, Principal investigator
Organization: Dhaka Medical College
Phone: 01912270803 ext +88
EMail: reazdmc22@yahoo.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Reaz Mahmud, Dhaka Medical College
ClinicalTrials.gov Identifier: NCT04523831    
Other Study ID Numbers: ERC-DMC/ECC/2020/117
First Submitted: August 19, 2020
First Posted: August 24, 2020
Results First Submitted: September 30, 2020
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020