Trial Outcomes & Findings for Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19 (NCT NCT04372628)
NCT ID: NCT04372628
Last Updated: 2024-02-28
Results Overview
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
452 participants
Primary outcome timeframe
Day 1 to Day 15
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
Group 1- Hydroxychloroquine
Hydroxychloroquine 400 mg orally twice daily for two doses (Day 1), then 200 mg twice daily for subsequent eight doses (Day 2-5), then placebo twice daily for subsequent eighteen doses (Day 6-14).
Arm Terminated 6/22/2020
|
Group 2 - Lopinavir/Ritonavir
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
Placebo Group 1: matched to Hydroxychloroquine orally twice daily for 14 days Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
221
|
227
|
|
Overall Study
COMPLETED
|
3
|
216
|
221
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Early Therapies During Non-hospitalized Outpatient Window for COVID-19
Baseline characteristics by cohort
| Measure |
Group 1- Hydroxychloroquine
n=4 Participants
Hydroxychloroquine 400 mg orally twice daily for two doses (Day 1), then 200 mg twice daily for subsequent eight doses (Day 2-5), then placebo twice daily for subsequent eighteen doses (Day 6-14).
Arm Terminated 6/22/2020
|
Group 2 - Lopinavir/Ritonavir
n=221 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 Participants
Placebo Group 1: matched to Hydroxychloroquine orally twice daily for 14 days Placebo Group 2: unmatched orally twice daily for 14 days
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
439 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
417 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
377 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
221 participants
n=7 Participants
|
227 participants
n=5 Participants
|
452 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: Includes all randomized participants, Unknown represents those with no daily surveys submitted over the first 15 study days
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=221 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Death
|
0 Participants
|
0 Participants
|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Hospitalized on Mechanical Ventilation/ECMO
|
1 Participants
|
0 Participants
|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Hospitalized on Supplemental Oxygen
|
5 Participants
|
4 Participants
|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Hospitalized, Not on Supplemental Oxygen
|
1 Participants
|
2 Participants
|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Not Hospitalized, Symptomatic, Limitations to Daily Activities
|
187 Participants
|
191 Participants
|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Not Hospitalized, Symptomatic, No Limitations to Daily Activities
|
10 Participants
|
14 Participants
|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Not Hospitalized, No Symptoms, No Limitations to Daily Activities
|
12 Participants
|
10 Participants
|
|
Modified COVID Ordinal Outcomes Scale: Study Day 15 (Group 2 and Placebo Control Group)
Unknown (no participant response)
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: on or at Day 8Population: 41 participants did not complete a survey in Group 2 34 participants did not complete a survey in the Placebo Control Group
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=221 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Death
|
0 Participants
|
0 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Hospitalized on Mechanical Ventilation/ECMO
|
1 Participants
|
0 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Hospitalized on Supplemental Oxygen
|
2 Participants
|
1 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Hospitalized, Not on Supplemental Oxygen
|
0 Participants
|
0 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Not Hospitalized, Symptomatic, Limitations to Daily Activities
|
76 Participants
|
61 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Not Hospitalized, Symptomatic, No Limitations to Daily Activities
|
28 Participants
|
51 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Not Hospitalized, No Symptoms, No Limitations to Daily Activities
|
73 Participants
|
80 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 8 (Group 2 and Placebo Control Group)
Unknown (No participant response)
|
41 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: on or at Day 29Population: 58 participants did not complete a survey in Group 2; 38 participants did not complete a survey in the Placebo Control Group.
Improvement of clinical condition of the participant defined by the Modified COVID Ordinal Outcomes Scale (Modified from the COVID-19 WHO ordinal Outcomes score to fit the outpatient setting). This scale reflects a range of participants from dead to not hospitalized and with no limitations to activities of daily living. A score of 1 is "death", 2 is "Hospitalized on mechanical ventilation or extracorporeal membrane oxygenator (ECMO)", 3 is "Hospitalized on supplemental oxygen", 4 is "Hospitalized not on supplemental oxygen", 5 is "Not hospitalized with symptoms and limitation in activity", 6 is "Not hospitalized with symptoms but with no limitation in activity", 7 is "Not hospitalized without symptoms nor limitation in activity". COVID outcomes are more severe at the lower end of the scale and milder at the higher end of the scale for this outpatient trial.
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=221 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Death
|
1 Participants
|
0 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Hospitalized on Supplemental Oxygen
|
1 Participants
|
0 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Hospitalized, Not on Supplemental Oxygen
|
1 Participants
|
1 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Not Hospitalized, Symptomatic, Limitations to Daily Activities
|
9 Participants
|
11 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Not Hospitalized, Symptomatic, No Limitations to Daily Activities
|
11 Participants
|
16 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Not Hospitalized, No Symptoms, No Limitations to Daily Activities
|
140 Participants
|
161 Participants
|
|
Modified COVID Ordinal Outcome Scale: Study Day 29 (Group 2 and Placebo Control Group)
Unknown (no participant response)
|
58 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Number of patients hospitalized from Day 1 to 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=221 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Number of Patients Hospitalized: Day 1 to 29 (Group 2 and Placebo Control Group)
Hospitalized
|
7 Participants
|
6 Participants
|
|
Number of Patients Hospitalized: Day 1 to 29 (Group 2 and Placebo Control Group)
Non-hospitalized
|
214 Participants
|
221 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Those with a recorded hospitalization
Number of days from enrollment to hospitalization (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=7 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=6 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Time to Hospitalization Day 1 to Day 29 (Group 2 and Placebo Control Group)
|
6 days
Interval 2.0 to 11.0
|
7 days
Interval 3.0 to 13.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: If a respondent did not report symptoms on any survey (e.g., if they resolved before receiving the medication), they were not included in the time to symptom resolution based on how we worded it in the SAP (i.e., time from medication receipt to resolution)
Number of days from enrollment to resolution of COVID-19 symptoms (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=208 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=221 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Time to Symptom Resolution: Day 1 to Day 29 (Group 2 and Placebo Control Group)
|
11 days
Interval 8.0 to 29.0
|
11 days
Interval 7.0 to 29.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Survival status (All-cause, all-location mortality) from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=221 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
All-cause, All-location Mortality: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Died
|
1 Participants
|
0 Participants
|
|
All-cause, All-location Mortality: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Alive
|
173 Participants
|
195 Participants
|
|
All-cause, All-location Mortality: Day 1 to Day 29 (Group 2 and Placebo Control Group)
Unknown
|
47 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Participants who never filled out a daily survey were excluded since we could not derive oxygen status. We present the median (IQR), and with almost all participants having no days on supplemental oxygen (or with other outcomes); Median (Q1, Q3) all are 17. 5 participants in Group 2 and 6 participants in the placebo never filled out the daily survey.
Number of Days without oxygen Day 1 to Day 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=221 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Oxygen-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
|
17 days
Interval 17.0 to 17.0
|
17 days
Interval 17.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Related to outcome 6, if symptoms resolved before receiving medication they were not included in this outcome. 13 participants in Group 2 and 6 participants in Placebo Control group did not fill out the data relevant to tracking fever-free days.
Number of days without fever from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=208 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=221 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Fever-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
|
16 days
Interval 14.0 to 17.0
|
17 days
Interval 15.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Related to outcome 8, if no daily surveys were completed, we could not derive ventilation status. We present the median (IQR), and with almost all participants having no days on a ventilator; Median (Q1, Q3) all are 17. There was no data for 5 participants in Group 2 and 6 participants in the Placebo Control Group.
Number of days without ventilator use from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=216 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=221 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Ventilator-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
|
17 days
Interval 17.0 to 17.0
|
17 days
Interval 17.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Related to outcome 8, if no daily surveys were completed, we could not determine ICU-free days. We present the median (IQR), and with almost all participants having no days in the ICU; Median (Q1, Q3) all are 17.
Number of days outside the ICU from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=216 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=221 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
ICU-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
|
17 days
Interval 17.0 to 17.0
|
17 days
Interval 17.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: Related to outcome 8, if no daily surveys were completed we could not determine ICU-free days. We present the median (IQR), and with almost all participants having no hospitalized days; Median (Q1, Q3) all are 17.
Number of days outside the hospital from Day 1 to Day 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=208 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=221 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Hospital-free Days: Day 1 to Day 29 (Group 2 and Placebo Control Group)
|
17 days
Interval 17.0 to 17.0
|
17 days
Interval 17.0 to 17.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 29Population: We present the median (IQR), with almost all participants having vasopressor-free days throughout primary follow-up; Median (Q1, Q3) all are 17.
Number of vasopressor-free days through Study Day 29 (Group 2 and Placebo Control Group)
Outcome measures
| Measure |
Group 2 - Lopinavir/Ritonavir
n=216 Participants
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=221 Participants
Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|
|
Vasopressor-free Days Through Study Day 29 (Group 2 and Placebo Control Group)
|
17 days
Interval 17.0 to 17.0
|
17 days
Interval 17.0 to 17.0
|
Adverse Events
Group 1- Hydroxychloroquine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2 - Lopinavir/Ritonavir
Serious events: 2 serious events
Other events: 203 other events
Deaths: 1 deaths
Placebo Control Group
Serious events: 1 serious events
Other events: 211 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1- Hydroxychloroquine
n=4 participants at risk
Hydroxychloroquine 400 mg orally twice daily for two doses (Day 1), then 200 mg twice daily for subsequent eight doses (Day 2-5), then placebo twice daily for subsequent eighteen doses (Day 6-14).
Arm Terminated 6/22/2020
|
Group 2 - Lopinavir/Ritonavir
n=221 participants at risk
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 participants at risk
Placebo Group 1: matched to Hydroxychloroquine orally twice daily for 14 days Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|---|
|
Infections and infestations
Lung Infection
|
0.00%
0/4 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.45%
1/221 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.00%
0/227 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.45%
1/221 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.00%
0/227 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/4 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.45%
1/221 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.00%
0/227 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/4 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.00%
0/221 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.44%
1/227 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/4 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.00%
0/221 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.44%
1/227 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.00%
0/221 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
0.44%
1/227 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
Other adverse events
| Measure |
Group 1- Hydroxychloroquine
n=4 participants at risk
Hydroxychloroquine 400 mg orally twice daily for two doses (Day 1), then 200 mg twice daily for subsequent eight doses (Day 2-5), then placebo twice daily for subsequent eighteen doses (Day 6-14).
Arm Terminated 6/22/2020
|
Group 2 - Lopinavir/Ritonavir
n=221 participants at risk
Lopinavir/Ritonavir 400 mg/100 mg orally twice daily for twenty-eight doses (Days 1-14)
Lopinavir/Ritonavir 400 mg/100 mg: Lopinavir/Ritonavir tablets
|
Placebo Control Group
n=227 participants at risk
Placebo Group 1: matched to Hydroxychloroquine orally twice daily for 14 days Placebo Group 2: unmatched orally twice daily for 14 days
|
|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
25.0%
1/4 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
50.7%
112/221 • Number of events 112 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
52.4%
119/227 • Number of events 119 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
2/4 • Number of events 2 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
54.3%
120/221 • Number of events 120 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
47.1%
107/227 • Number of events 107 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
72.4%
160/221 • Number of events 160 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
53.7%
122/227 • Number of events 122 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
52.0%
115/221 • Number of events 115 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
45.4%
103/227 • Number of events 103 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
|
General disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
63.8%
141/221 • Number of events 141 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
49.8%
113/227 • Number of events 113 • Enrollment - Study Day 16 (or 48 hours after completion of the study drug administration) Deaths were observed through day 29 per the secondary outcome Measure 7 specification, but AEs were only collected as AEs through study Day 16.
Adverse Event: Any untoward medical occurrence associated with the use of a drug or a study procedure, whether or not considered drug related. The Investigators determined daily if any adverse events occurred during the period from enrollment through study day 16 (or 48 hours after completion of the study drug administration).
|
Additional Information
Clinical Trials Operations Manager
Vanderbilt University Medical Center
Phone: (615) 875-3080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place