Trial Outcomes & Findings for Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection (NCT NCT04523831)

NCT ID: NCT04523831

Last Updated: 2020-10-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 400 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2020-10-09

Participant Flow

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.

Of 556 patients who screened and were assessed for eligibility, 400 underwent randomization. Total 200 patients received active drug and 200 patient received placebo.

Participant milestones

Measure	Ivermectin and Doxycycline 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	Placebo Standard treatment
Overall Study STARTED	200	200
Overall Study COMPLETED	183	180
Overall Study NOT COMPLETED	17	20

Reasons for withdrawal

Measure	Ivermectin and Doxycycline 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	Placebo Standard treatment
Overall Study Lost to Follow-up	15	17
Overall Study Death	0	3
Overall Study Adverse Event	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ivermectin and Doxycycline n=200 Participants 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	Placebo n=200 Participants Standard treatment	Total n=400 Participants Total of all reporting groups
Age, Continuous	40.72 years STANDARD_DEVIATION 14.28 • n=200 Participants	38.47 years STANDARD_DEVIATION 11.89 • n=200 Participants	39.59 years STANDARD_DEVIATION 13.17 • n=400 Participants
Sex: Female, Male Female	77 Participants n=200 Participants	88 Participants n=200 Participants	165 Participants n=400 Participants
Sex: Female, Male Male	123 Participants n=200 Participants	112 Participants n=200 Participants	235 Participants n=400 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 7 days

Population: Intention to treat analysis. Linear logistic regression

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.

Outcome measures

Measure	Ivermectin Plus Doxycycline n=183 Participants Ivermectin plus Doxycycline plus Standard of care	Placebo n=180 Participants Placebo plus Standard of care
Number of Patients With Early Clinical Improvement	111 Participants	80 Participants

PRIMARY outcome

Timeframe: 12 days

Population: Intention to treat analysis. Binary logistic regression

Number of the patients required more than 12 days for clinical improvement as defined above.

Outcome measures

Measure	Ivermectin Plus Doxycycline n=183 Participants Ivermectin plus Doxycycline plus Standard of care	Placebo n=180 Participants Placebo plus Standard of care
Number of Participants With Late Clinical Recovery	42 Participants	67 Participants

SECONDARY outcome

Timeframe: 1 month

Population: Intention to treat analysis. Binary Logistic regression

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).

Outcome measures

Measure	Ivermectin Plus Doxycycline n=183 Participants Ivermectin plus Doxycycline plus Standard of care	Placebo n=180 Participants Placebo plus Standard of care
Number of Patients Having Clinical Deterioration.	16 Participants	32 Participants

SECONDARY outcome

Timeframe: 14 days

Population: Intention to treat analysis. Binary logistic regression

Number of Patients remain positive for RT-PCR of Covid-19 at day 14 after the day of initial positivity.

Outcome measures

Measure	Ivermectin Plus Doxycycline n=183 Participants Ivermectin plus Doxycycline plus Standard of care	Placebo n=180 Participants Placebo plus Standard of care
Number of Patients Remain Persistently Positive for RT-PCR of Covid-19	14 Participants	36 Participants

Adverse Events

Ivermectin and Doxycycline

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Ivermectin and Doxycycline n=183 participants at risk Ivermectin Plus Doxycycline plus standard of care	Placebo n=180 participants at risk Placebo plus standard of care
Gastrointestinal disorders Erosive esophagitis	1.1% 2/183 • Number of events 2 • 1 month	0.00% 0/180 • 1 month

Other adverse events

Measure	Ivermectin and Doxycycline n=183 participants at risk Ivermectin Plus Doxycycline plus standard of care	Placebo n=180 participants at risk Placebo plus standard of care
Gastrointestinal disorders Non ulcer Dyspepsia	3.8% 7/183 • Number of events 7 • 1 month	0.00% 0/180 • 1 month

Additional Information

Dr. Reaz Mahmud, Principal investigator

Dhaka Medical College

Phone: 01912270803

Email: reazdmc22@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place