Trial Outcomes & Findings for Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment (NCT NCT04673214)
NCT ID: NCT04673214
Last Updated: 2021-08-16
Results Overview
Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
114 participants
Primary outcome timeframe
14 days
Results posted on
2021-08-16
Participant Flow
Recruitment begins on December 16, 2020 in the Family Medicine Unit No.13 and in the Family Medicine Unit No.20 of the Mexican Institute of Social Security.
There were no excluded patients.
Participant milestones
| Measure |
Triple Therapy
65 triple therapy patients received the assigned intervention with Azithromycin tablets 500 mg 1 tablet in a single dose the first day and then half a tablet (250 mg) orally every 24 4 days, ivermectin tablets of 200 mcg calculated according to your weight and dose, will be every 24 hours for 2 days and Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days and Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
Double Therapy
46 double therapy patients received the assigned intervention with Azithromycin 500 mg tablets 1 single dose tablet on the first day and then half a tablet (250 mg) orally every 24 4 days and rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days with Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
47
|
|
Overall Study
Lost to Follow up
|
2
|
1
|
|
Overall Study
COMPLETED
|
65
|
46
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment
Baseline characteristics by cohort
| Measure |
Double Therapy
n=46 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
Triple Therapy
n=65 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS \<80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS\> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
Total
n=111 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
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mestizo Mexicans
|
46 participants
n=5 Participants
|
65 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
46 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Age
21-30 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age
31-40 years
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age
41-50 years
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age
51-60 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age
61-70 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age
≥ 71 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Occupation
Part time
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Occupation
Full time
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Occupation
Housewife
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Occupation
Pensioner
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Occupation
Unemployed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Civil Status
Single
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Civil Status
Married
|
25 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Civil Status
Widower
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Civil Status
Free Union
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Civil Status
Divorced
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Primary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
High school
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
Preparatory
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Education
Technical career
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
Degree
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Education
Others
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.
Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy.
Outcome measures
| Measure |
DOUBLE THERAPY
n=46 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
TRIPLE THERAPY
n=65 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS \<80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS\> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
|---|---|---|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Cough
|
7 days
Standard Deviation 5.4
|
7 days
Standard Deviation 5.6
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Rhinorrhea
|
3 days
Standard Deviation 4.8
|
3 days
Standard Deviation 4.3
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Odynophagia
|
5 days
Standard Deviation 4.8
|
5 days
Standard Deviation 5.4
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Diarrhea
|
2 days
Standard Deviation 4
|
1 days
Standard Deviation 2.2
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Myalgia
|
6 days
Standard Deviation 5.6
|
5 days
Standard Deviation 5
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Minor symptoms
|
3 days
Standard Deviation 2.7
|
3 days
Standard Deviation 2.5
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
treatment start day
|
4 days
Standard Deviation 1.9
|
4 days
Standard Deviation 1.6
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Fever
|
2 days
Standard Deviation 3.4
|
2 days
Standard Deviation 3.2
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Headache
|
6 days
Standard Deviation 5.2
|
5 days
Standard Deviation 4.9
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Anosmia
|
5 days
Standard Deviation 5.8
|
6 days
Standard Deviation 5.9
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Conjunctivitis
|
2 days
Standard Deviation 4.1
|
1 days
Standard Deviation 2.9
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Chest pain
|
5 days
Standard Deviation 5.6
|
4 days
Standard Deviation 4.8
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Dyspnea of movement
|
2 days
Standard Deviation 4.1
|
2 days
Standard Deviation 3.9
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Dysnea at rest
|
1 days
Standard Deviation 3.3
|
2 days
Standard Deviation 3.6
|
|
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Major symptoms
|
5 days
Standard Deviation 3.1
|
5 days
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis
Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated using Pearson's Chi-square test as categorical variables.
Outcome measures
| Measure |
DOUBLE THERAPY
n=46 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
TRIPLE THERAPY
n=65 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS \<80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS\> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
|---|---|---|
|
Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS
Number of Participants with Improvement in Clinical Evaluation
|
44 Participants
|
59 Participants
|
|
Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS
Number of Participants with Therapeutic Failure
|
2 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysPopulation: Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%
Statistical differences were evaluated using Student's t test for quantitative variables. The average duration of days with clinical symptoms of COVID-19 under early intervention treatment by outcome in the improvement of the modification of the clinical evolution of symptoms vs. therapeutic failure.
Outcome measures
| Measure |
DOUBLE THERAPY
n=103 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
TRIPLE THERAPY
n=8 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS \<80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS\> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
|---|---|---|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Fever
|
2 Days
Standard Deviation 3.3
|
1 Days
Standard Deviation 1.7
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Headache
|
6 Days
Standard Deviation 5
|
2 Days
Standard Deviation 2
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Rhinorrhea
|
4 Days
Standard Deviation 4.6
|
1 Days
Standard Deviation 1.4
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Conjunctivitis
|
1 Days
Standard Deviation 3.6
|
1 Days
Standard Deviation 1.4
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Chest Pain
|
4 Days
Standard Deviation 5.2
|
1 Days
Standard Deviation 1.5
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Dyspnea of movement
|
2 Days
Standard Deviation 4.1
|
3 Days
Standard Deviation 2.9
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Dyspnea at Rest
|
1 Days
Standard Deviation 3.5
|
3 Days
Standard Deviation 2.9
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Major Symptoms
|
5 Days
Standard Deviation 3.3
|
2 Days
Standard Deviation 1.5
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Minor Symptoms
|
3 Days
Standard Deviation 2.6
|
2 Days
Standard Deviation 1.2
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Cough
|
7 Days
Standard Deviation 5.6
|
4 Days
Standard Deviation 3.3
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Odynophagia
|
5 Days
Standard Deviation 5.2
|
2 Days
Standard Deviation 3.2
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Diarrhea
|
2 Days
Standard Deviation 3.2
|
1 Days
Standard Deviation 2.1
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Myalgia
|
6 Days
Standard Deviation 5.4
|
5 Days
Standard Deviation 2
|
|
Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
Anosmia
|
6 Days
Standard Deviation 6
|
2 Days
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 daysPopulation: Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%; A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.
Survival analysis. The time it takes for 50% of COVID-19 patients to improve symptoms during a 14-day follow-up with dual therapy vs. triple therapy
Outcome measures
| Measure |
DOUBLE THERAPY
n=46 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
TRIPLE THERAPY
n=65 Participants
The following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS \<80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS\> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
|---|---|---|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Cought
|
16 Participants
|
26 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Fever
|
10 Participants
|
7 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Odynophagia
|
26 Participants
|
35 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Rhinorrhea
|
17 Participants
|
16 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Anosmia
|
34 Participants
|
33 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Conjunctivitis
|
13 Participants
|
8 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Diarrhea
|
8 Participants
|
11 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Dyspnea at rest
|
9 Participants
|
16 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Headache
|
6 Participants
|
7 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Myalgia
|
23 Participants
|
35 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Chest pain
|
25 Participants
|
33 Participants
|
|
Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
Dyspnea of movement
|
14 Participants
|
18 Participants
|
Adverse Events
Dual Therapy Adverse Event
Serious events: 0 serious events
Other events: 39 other events
Deaths: 1 deaths
Adverse Event Triple Therapy
Serious events: 0 serious events
Other events: 49 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dual Therapy Adverse Event
n=46 participants at risk
Record of adverse reactions of Blood and lymphatic system disorders, Heartdisorders, Ear and labyrinth disorders,Gastrointestinal disorders and Musculoskeletal and connective tissue disorders with the following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
Adverse Event Triple Therapy
n=65 participants at risk
Record of adverse reactions of Blood and lymphatic system disorders, Heartdisorders, Ear and labyrinth disorders,Gastrointestinal disorders and Musculoskeletal and connective tissue disorders with the following medications were taken for this group: Azithromycin 500 mg tablets take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days; Ivermectin 6 mg tablets take as follows 2 TABLETS \<80 KG orally, 3 TABLETS between 80-110 kg orally, 4 TABLETS\> 110kg orally, every 24 hours for 2 days; Rivaroxaban 10 mg tablets take 1 every 24 hours for 10 days; Paracetamol 500 mg orally take 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
asthenia
|
52.2%
24/46 • Number of events 24 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
27.7%
18/65 • Number of events 18 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
|
Cardiac disorders
Palpitations
|
8.7%
4/46 • Number of events 4 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
7.7%
5/65 • Number of events 5 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
|
Ear and labyrinth disorders
Tinnitus
|
13.0%
6/46 • Number of events 6 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
15.4%
10/65 • Number of events 10 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
|
Gastrointestinal disorders
Nausea
|
19.6%
9/46 • Number of events 9 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
27.7%
18/65 • Number of events 18 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
|
Blood and lymphatic system disorders
Ecchymosis
|
4.3%
2/46 • Number of events 2 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
3.1%
2/65 • Number of events 2 • Adverse event data was collected was 14 days.
No presence of serious adverse events
|
Additional Information
Dr. GILBERTO CRUZ ARTEAGA
MEXICAN SOCIAL SECURITY INSTITUTE
Phone: 55 87 44 22
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place