Trial Outcomes & Findings for Treatment for COVID-19 in High-Risk Adult Outpatients (NCT NCT04354428)
NCT ID: NCT04354428
Last Updated: 2022-08-08
Results Overview
Resting blood oxygen saturation (SpO2\<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
289 participants
Primary outcome timeframe
28 days from enrolment
Results posted on
2022-08-08
Participant Flow
This was a remotely conducted study. Participants who completed the informed consent process but did not complete the enrollment process after receiving the study materials are "started" but are not considered to have "completed enrollment". This explains the discrepancy between "Started" and "Completed Enrollment"
Participant milestones
| Measure |
Ascorbic Acid and Folic Acid
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Lopinavir-ritonavir
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
71
|
77
|
29
|
29
|
|
Overall Study
Completed Enrollment
|
80
|
65
|
74
|
27
|
28
|
|
Overall Study
COMPLETED
|
75
|
62
|
71
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
6
|
10
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for COVID-19 in High-Risk Adult Outpatients
Baseline characteristics by cohort
| Measure |
Ascorbic Acid and Folic Acid
n=83 Participants
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=71 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=77 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Lopinavir-ritonavir
n=29 Participants
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid
n=29 Participants
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18-29 years
|
21 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
79 Participants
n=10 Participants
|
|
Age, Customized
30-39 years
|
26 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
93 Participants
n=10 Participants
|
|
Age, Customized
40-49 years
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
56 Participants
n=10 Participants
|
|
Age, Customized
50-59 years
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
35 Participants
n=10 Participants
|
|
Age, Customized
60-69 years
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
22 Participants
n=10 Participants
|
|
Age, Customized
70-80 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
45 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
168 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Male
|
38 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
121 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
82 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
206 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
39 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
35 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
159 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
38 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
|
High Risk
|
48 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
147 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 days from enrolmentPopulation: This outcome was analyzed in the first arm of the platform trial (Ascorbic Acid/Folic Acid HCQ, HCQ/AZ) among the high risk cohort only. The mITT cohort included only those without LRTI at baseline.
Resting blood oxygen saturation (SpO2\<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough
Outcome measures
| Measure |
Lopinavir-ritonavir
n=29 Participants
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid and Folic Acid
n=47 Participants
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=36 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=44 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Ascorbic Acid
n=29 Participants
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Number of Persons With Lower Respiratory Tract Infection (LRTI), Defined as Resting Blood Oxygen Saturation (SpO2<93%) Level Sustained for 2 Readings 2 Hours Apart and Presence of Subjective Dyspnea or Cough
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 28 after enrolmentNumber of participants with hospitalization or mortality
Outcome measures
| Measure |
Lopinavir-ritonavir
n=29 Participants
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid and Folic Acid
n=83 Participants
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=71 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=77 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Ascorbic Acid
n=29 Participants
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Number of Participants With Hospitalization or Mortality
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 14 after enrolmentPopulation: Included the mITT viral shedding cohort, which includes the mITT cohort participants who do not meet the definition for clearance of viral shedding at baseline (day 1 and 2 swabs negative).
Time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs
Outcome measures
| Measure |
Lopinavir-ritonavir
n=16 Participants
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid and Folic Acid
n=52 Participants
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=49 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=51 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Ascorbic Acid
n=21 Participants
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Time to Clearance of Nasal SARS-CoV-2
|
4 Days
Interval 3.0 to
Due to limited participants with events within the followup period, unable to calculate upper confidence interval limit
|
7 Days
Interval 6.0 to 10.0
|
5 Days
Interval 4.0 to 6.0
|
6 Days
Interval 4.0 to 8.0
|
5 Days
Interval 3.0 to 9.0
|
PRIMARY outcome
Timeframe: Day 1 through Day 14 after enrolmentPopulation: mITT Disease Resolution cohort includes participants who meet the COVID-19 disease criteria on day 1. The symptom resolution rate was the primary outcome of the lopinavir-ritonavir adaptive platform arms (lopinavir-ritonavir and ascorbic acid).
COVID-19 symptoms are based on the following criteria: * At least TWO of the following symptoms: Fever (≥ 38ºC), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s), OR * At least ONE of the following symptoms: cough, shortness of breath or difficulty breathing, OR * Severe respiratory illness with at least 1 of the following: * Clinical or radiological evidence of pneumonia, OR * Acute respiratory distress syndrome (ARDS), OR * LRTI, defined by resting SpO2\<93% sustained for 2 readings 2 hours apart AND presence of subjective dyspnea or cough Death or COVID-19-related hospitalizations will count as a failure to resolve symptoms.
Outcome measures
| Measure |
Lopinavir-ritonavir
n=27 Participants
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid and Folic Acid
n=72 Participants
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=60 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=65 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Ascorbic Acid
n=25 Participants
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Time to Resolution of COVID-19 Symptom Resolution in Days
|
NA Days
Due to limited participants with events within the followup period, unable to calculate median or confidence interval limit
|
11.5 Days
Interval 8.5 to
Due to limited participants with events within the followup period, unable to calculate upper confidence interval limit
|
10.5 Days
Interval 6.5 to
Due to limited participants with events within the followup period, unable to calculate upper confidence interval limit
|
NA Days
Interval 9.5 to
Due to limited participants with events within the followup period, unable to calculate median or upper confidence interval limit
|
NA Days
Interval 10.5 to
Due to limited data, unable to calculate Due to limited participants with events within the followup period, unable to calculate median and upper confidence interval limit
|
SECONDARY outcome
Timeframe: 28 days from enrolmentPopulation: All enrolled participants
Serious adverse events (including death and hospitalization) and adverse events resulting in treatment discontinuation
Outcome measures
| Measure |
Lopinavir-ritonavir
n=29 Participants
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid and Folic Acid
n=83 Participants
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=71 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=77 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Ascorbic Acid
n=29 Participants
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events and Adverse Events Resulting in Treatment Discontinuation
|
9 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 days from enrolmentDuration of hospitalization among persons who become hospitalized with COVID-19 disease
Outcome measures
| Measure |
Lopinavir-ritonavir
n=29 Participants
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid and Folic Acid
n=83 Participants
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=71 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=77 Participants
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Ascorbic Acid
n=29 Participants
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
COVID-19-related Hospitalization Days
|
NA Days
Duration of hospitalization not assessed due to insufficient number of participants with events
|
NA Days
Duration of hospitalization not assessed due to insufficient number of participants with events
|
NA Days
Duration of hospitalization not assessed due to insufficient number of participants with events
|
NA Days
Duration of hospitalization not assessed due to insufficient number of participants with events
|
NA Days
Duration of hospitalization not assessed due to insufficient number of participants with events
|
Adverse Events
Ascorbic Acid and Folic Acid
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Hydroxychloroquine and Folic Acid
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Hydroxychloroquine and Azithromycin
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Lopinavir-ritonavir
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ascorbic Acid
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ascorbic Acid and Folic Acid
n=83 participants at risk
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=71 participants at risk
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=77 participants at risk
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Lopinavir-ritonavir
n=29 participants at risk
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid
n=29 participants at risk
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.6%
3/83 • Number of events 3 • 28 days
Participant reported AE
|
0.00%
0/71 • 28 days
Participant reported AE
|
2.6%
2/77 • Number of events 2 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
|
Cardiac disorders
Chest Pain
|
1.2%
1/83 • Number of events 1 • 28 days
Participant reported AE
|
1.4%
1/71 • Number of events 1 • 28 days
Participant reported AE
|
0.00%
0/77 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
0.00%
0/83 • 28 days
Participant reported AE
|
0.00%
0/71 • 28 days
Participant reported AE
|
0.00%
0/77 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
3.4%
1/29 • Number of events 1 • 28 days
Participant reported AE
|
|
Gastrointestinal disorders
hemorrhagic colitis
|
0.00%
0/83 • 28 days
Participant reported AE
|
0.00%
0/71 • 28 days
Participant reported AE
|
1.3%
1/77 • Number of events 1 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
|
Cardiac disorders
pericarditis
|
0.00%
0/83 • 28 days
Participant reported AE
|
1.4%
1/71 • Number of events 1 • 28 days
Participant reported AE
|
0.00%
0/77 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
Other adverse events
| Measure |
Ascorbic Acid and Folic Acid
n=83 participants at risk
Ascorbic acid 500 mg orally twice on Day 1, followed by 250 mg orally twice daily for 9 days + folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days (Days 2 to 5)
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Folic Acid
n=71 participants at risk
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + placebo (folic acid 800 µg orally once on Day 1, followed by 400 µg orally once daily for an additional 4 days \[Days 2 to 5\])
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Folic Acid: Eligible participants in a household will receive folic acid and an additional intervention drug
|
Hydroxychloroquine and Azithromycin
n=77 participants at risk
HCQ 400 mg orally twice on Day 1, followed by 200 mg orally twice daily for an additional 9 days (Days 2 to 10) + azithromycin 500 mg orally once on Day 1, followed by 250 mg orally once daily for an additional 4 days (Days 2 to 5).
Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
Azithromycin: Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
|
Lopinavir-ritonavir
n=29 participants at risk
LPV/r 800 mg-200 mg orally twice on Day 1, followed by 400 mg 100 mg orally twice daily for an additional 9 days (Days 2 to 10)
Lopinavir 200 MG / Ritonavir 50 MG \[Kaletra\]: Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
|
Ascorbic Acid
n=29 participants at risk
Ascorbic acid 1 gm orally twice on Day 1, followed by 500 mg orally twice daily for 9 days
Ascorbic Acid: Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Event leading to treatment discontinuation
|
2.4%
2/83 • Number of events 2 • 28 days
Participant reported AE
|
1.4%
1/71 • Number of events 1 • 28 days
Participant reported AE
|
3.9%
3/77 • Number of events 4 • 28 days
Participant reported AE
|
31.0%
9/29 • Number of events 13 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
|
Cardiac disorders
QT Prolongation
|
0.00%
0/83 • 28 days
Participant reported AE
|
2.8%
2/71 • Number of events 2 • 28 days
Participant reported AE
|
0.00%
0/77 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
|
Nervous system disorders
Headache
|
0.00%
0/83 • 28 days
Participant reported AE
|
1.4%
1/71 • Number of events 1 • 28 days
Participant reported AE
|
0.00%
0/77 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
|
Immune system disorders
Drug Reaction
|
0.00%
0/83 • 28 days
Participant reported AE
|
0.00%
0/71 • 28 days
Participant reported AE
|
2.6%
2/77 • Number of events 2 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
0.00%
0/29 • 28 days
Participant reported AE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place