Covid 19 Research using Clinical Trials (Home Page)
Standard CareWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug593 | CoYoT1 Care Wiki | 0.50 |
| drug1366 | Lopinavir-Ritonavir Drug Combination Wiki | 0.50 |
| drug1578 | Natural Honey Wiki | 0.50 |
| drug1282 | Ivermectin plus Nitazoxanide Wiki | 0.50 |
| drug343 | Bevacizumab Injection Wiki | 0.35 |
| drug1598 | Nitazoxanide Wiki | 0.18 |
| drug1822 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003922 | Diabetes Mellitus, Type 1 NIH | 0.25 |
| D007251 | Influenza, Human NIH | 0.15 |
| D018352 | Coronavirus Infections NIH | 0.06 |
| D014777 | Virus Diseases NIH | 0.06 |
| D013577 | Syndrome NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
| D011014 | Pneumonia NIH | 0.03 |
Correlated HPO Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100651 | Type I diabetes mellitus HPO | 0.25 |
| HP:0002090 | Pneumonia HPO | 0.03 |
There are 4 clinical trials
Clinical Trials
1 CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes
CoYoT1 to California (CTC) was initiated to develop a patient-centered, home telehealth care model for young adults (YA) ages 16-25 with T1D. It is a 2x2 factorial design, 15-month intervention. Eighty participants will be randomized to Standard Care or CoYoT1 Care, which is delivered by telehealth or in-person. CoYoT1 Care is a patient-centered care model that consists of three major components: shared decision making (patient and provider agree upon priorities for the medical visit), autonomy and supportive care (provider training in communication strategies such as motivational interviewing), and goal setting and action planning (provider training to coach YA in setting SMART goals, developing action plans, and designing follow up plans). Additionally, didactic expert-led sessions (Standard Care) or peer-led, YA-driven group sessions (CoYoT1 Care) are included. At the end of the study, a focus group will be completed to assist in determining which features YA felt were critical to their success from the telehealth intervention, group components, and provider behaviors. ***COVID-19 Update: Due to current hospital and clinical policy adaptation for COVID-19, all participants who were randomized into in-person appointments will now receive care via Telehealth. Telehealth has been implemented hospital-wide and will be the temporary delivery of care method during this pandemic. Participants have been notified of this change and given instruction on how to participate in a Telehealth appointment.
NCT03793673 Type Type 1 Diabetes Mellitus Behavioral: CoYoT1 Care Other: Standard Care MeSH:Diabetes Diabetes Mellitus, Type 1
HPO:Type I diabetes mellitus
Primary Outcomes
Description: Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Measure: Number of participants with completed appointments in telemedicine cohort Time: 12 months
Description: Patient online attendance as assessed using an online patient experience questionnaire - Polar Questions; Yes or no response questions related to patient's online appointment (i.e., did you have an online appointment? Did you attend your appointment?)
Measure: Number of participants with completed appointments in telemedicine cohort Time: 12 months
Description: In-person patient appointment attendance assessed using an online patient experience questionnaire. Polar questions; Yes or No response questions related to patient's in-person appointment (i.e., did you have an in-person appointment? Did you attend your in-person appointment?
Measure: Number of participants with completed medical appointments in standard care cohort Time: 12 months
Description: : Likert scale "Very dissatisfied" is 1, "Dissatisfied" is 2, "Neutral" is 3, "Satisfied" is 4, and "Very Satisfied" is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction
Measure: Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire Time: 12 months
Description: Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.
Measure: Provider Experience as assessed using the CAHPS survey Time: 12 months
Description: Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
Measure: Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire Time: [Time Frame: For each visit (until the end of study) - 12 months]
Description: Telehealth Utilization satisfaction as assessed using a telehealth satisfaction questionnaire. Likert scale; range 1-5, low values indicate low satisfaction and higher values indicate high satisfaction. Polar: Yes or No response questions, "Would you use telehealth again?" Open ended; patient comments about experience.
Measure: Provider Satisfaction as assessed using the Satisfaction Provider survey Time: 12 months
Description: Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating
Measure: Patient Experience Time: 12 months
Description: Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, "did you worry that your food would run out before you got money to buy more?" "have you or your family ever been unable to go to the doctor because of distance or transportation?"
Measure: Social Determinants of Health Tool Time: At 0 (baseline)
Secondary Outcomes
Description: Transportation cost to patient as assessed using a Transportation Questionnaire. Multiple choice questions about mode of transportation used to get to appointment, "driving own vehicle," "riding public transit," "ride with family member or friend." Open ended to assess cost of parking, bus fare.
Measure: Costs to Patients Time: 12 months
Description: Number of patients with need for a technology device (cellphone) as assessed using a Device Assessment questionnaire. Polar; Yes or No question about access to personal device patient has for online appointment, "do you have a personal device to access the internet?." Multiple choice questions about device; "Mobile phone," "Laptop," "Tablet," "Ethernet," "Wi-Fi."
Measure: Costs to Patients Time: 12 months
Description: Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Measure: Costs to Patients Time: 12 months
Description: Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, "have you had to be admitted to the hospital?" Open-ended question about number of time health services were used, "how many times were you admitted to the hospital for reasons related to diabetes?"
Measure: Cost to Instituition Time: 12 months
Description: Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to online appointment. "Did you attend your online appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"
Measure: Cost to Instituition Time: 12 months
Description: Cost to Institution as assessed using the In-Person Appointment questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"
Measure: Cost to Instituition Time: 12 months
Description: Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient
Measure: Cost to Instituition Time: 12 months
Description: Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, "camera and mic," "loading Webex platform."
Measure: Cost to Instituition Time: 12 months
Description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measure: Glycemic Control at Baseline Time: HbA1c for the last 12 months
Description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measure: Glycemic Control Progression Time: For each visit (until the end of study) - 12 months
Description: Cost to Payor as assessed using Health Care Utilization Online questionnaire. Polar; Yes and No questions about patient use of health services, "In the last 3 months, has 911 been called because of your diabetes?" Open-ended questions about rate of health service use, "how many times was 911 called?"
Measure: Cost to Payor Time: 12 months (monthly)
Description: Cost to payor as assessed using Clinic Cost, Preparation, and Delivery questionnaire for Providers or Staff. Open ended questions about length of training and technology used, along with any comments about appointment delivery.
Measure: Cost to Payor Time: 12 months
Description: Cost to payor as assessed using the Team Costs of Provider or Staff questionnaire. Open ended question asking about length of training and training required on "billing process," "data collection process," "camera and mic."
Measure: Cost to Payor Time: 12 months
Description: Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".
Measure: Cost to Payor as as assessed using the Team Costs- YA Time: 12 months
Other Outcomes
Description: Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.
Measure: Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire. Time: At 0 (baseline) and 12 months (after visit 4)
Description: "Rarely or none of the time (less than 1 day)" is 0, "Some or a little of the time (1-2 days)" is 1, "Occasionally or a moderate amount of time" is 2, "Most or all of the time (5-7 days)" is 3. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measure: Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D) Time: At 0 (baseline) and 12 months (after visit 4)
Description: Likert scale; "Excellent" is 1, "Very good" is 2, "Good" is 3, "Fair" is 4, and "Poor" is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.
Measure: Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure Time: At 0 (baseline) and 12 months (after visit 4)
Description: Likert scale; "Not a problem" is 1, "A slight problem" is 2, "A moderate problem" is 3, "Somewhat serious problem" is 4, "A Serious Problem" is 5, and "A very serious problem" is 6. There are 4 subscales that address the dimensions of distress and to score, the appropriate item(s) are summed and divided by appropriate number. A mean item score of 3 or higher is considered moderate distress.
burden, regimen distress, interpersonal distress and physician distress; likert scale
Measure: Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS) Time: At 0 (baseline) and 12 months (after visit 4)
Description: Diabetes-related psychosocial self-efficacy as assessed using the Diabetes Empowerment Scale Short Form (DES-SF); Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
Measure: Assessment of Diabetes-Related Psychosocial Self-Efficacy Time: At 0 (baseline) and 12 months (after visit 4)
Description: Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"
Measure: Self Care - Realted to Diabetes as assessed by Self-Care questionnaire Time: [At 0 (baseline) and each visit (until the end of study) - 12 months]
2 The Efficacy of Natural Honey in Patients Infected With Novel Coronavirus (COVID-19) : A Randomized, Controlled ,Single Masked , Investigator Initiated, Multi-center Trial
Primary Outcomes
Description: Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
Measure: Number of participants with completed appointments in telemedicine cohort Time: 12 monthsDescription: Patient online attendance as assessed using an online patient experience questionnaire - Polar Questions; Yes or no response questions related to patient's online appointment (i.e., did you have an online appointment? Did you attend your appointment?)
Measure: Number of participants with completed appointments in telemedicine cohort Time: 12 monthsDescription: In-person patient appointment attendance assessed using an online patient experience questionnaire. Polar questions; Yes or No response questions related to patient's in-person appointment (i.e., did you have an in-person appointment? Did you attend your in-person appointment?
Measure: Number of participants with completed medical appointments in standard care cohort Time: 12 monthsDescription: : Likert scale "Very dissatisfied" is 1, "Dissatisfied" is 2, "Neutral" is 3, "Satisfied" is 4, and "Very Satisfied" is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction
Measure: Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire Time: 12 monthsDescription: Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.
Measure: Provider Experience as assessed using the CAHPS survey Time: 12 monthsDescription: Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
Measure: Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire Time: [Time Frame: For each visit (until the end of study) - 12 months]Description: Telehealth Utilization satisfaction as assessed using a telehealth satisfaction questionnaire. Likert scale; range 1-5, low values indicate low satisfaction and higher values indicate high satisfaction. Polar: Yes or No response questions, "Would you use telehealth again?" Open ended; patient comments about experience.
Measure: Provider Satisfaction as assessed using the Satisfaction Provider survey Time: 12 monthsDescription: Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating
Measure: Patient Experience Time: 12 monthsDescription: Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, "did you worry that your food would run out before you got money to buy more?" "have you or your family ever been unable to go to the doctor because of distance or transportation?"
Measure: Social Determinants of Health Tool Time: At 0 (baseline)Secondary Outcomes
Description: Transportation cost to patient as assessed using a Transportation Questionnaire. Multiple choice questions about mode of transportation used to get to appointment, "driving own vehicle," "riding public transit," "ride with family member or friend." Open ended to assess cost of parking, bus fare.
Measure: Costs to Patients Time: 12 monthsDescription: Number of patients with need for a technology device (cellphone) as assessed using a Device Assessment questionnaire. Polar; Yes or No question about access to personal device patient has for online appointment, "do you have a personal device to access the internet?." Multiple choice questions about device; "Mobile phone," "Laptop," "Tablet," "Ethernet," "Wi-Fi."
Measure: Costs to Patients Time: 12 monthsDescription: Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
Measure: Costs to Patients Time: 12 monthsDescription: Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, "have you had to be admitted to the hospital?" Open-ended question about number of time health services were used, "how many times were you admitted to the hospital for reasons related to diabetes?"
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to online appointment. "Did you attend your online appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using the In-Person Appointment questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient
Measure: Cost to Instituition Time: 12 monthsDescription: Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, "camera and mic," "loading Webex platform."
Measure: Cost to Instituition Time: 12 monthsDescription: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measure: Glycemic Control at Baseline Time: HbA1c for the last 12 monthsDescription: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
Measure: Glycemic Control Progression Time: For each visit (until the end of study) - 12 monthsDescription: Cost to Payor as assessed using Health Care Utilization Online questionnaire. Polar; Yes and No questions about patient use of health services, "In the last 3 months, has 911 been called because of your diabetes?" Open-ended questions about rate of health service use, "how many times was 911 called?"
Measure: Cost to Payor Time: 12 months (monthly)Description: Cost to payor as assessed using Clinic Cost, Preparation, and Delivery questionnaire for Providers or Staff. Open ended questions about length of training and technology used, along with any comments about appointment delivery.
Measure: Cost to Payor Time: 12 monthsDescription: Cost to payor as assessed using the Team Costs of Provider or Staff questionnaire. Open ended question asking about length of training and training required on "billing process," "data collection process," "camera and mic."
Measure: Cost to Payor Time: 12 monthsDescription: Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".
Measure: Cost to Payor as as assessed using the Team Costs- YA Time: 12 monthsOther Outcomes
Description: Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.
Measure: Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire. Time: At 0 (baseline) and 12 months (after visit 4)Description: "Rarely or none of the time (less than 1 day)" is 0, "Some or a little of the time (1-2 days)" is 1, "Occasionally or a moderate amount of time" is 2, "Most or all of the time (5-7 days)" is 3. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Measure: Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D) Time: At 0 (baseline) and 12 months (after visit 4)Description: Likert scale; "Excellent" is 1, "Very good" is 2, "Good" is 3, "Fair" is 4, and "Poor" is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.
Measure: Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure Time: At 0 (baseline) and 12 months (after visit 4)Description: Likert scale; "Not a problem" is 1, "A slight problem" is 2, "A moderate problem" is 3, "Somewhat serious problem" is 4, "A Serious Problem" is 5, and "A very serious problem" is 6. There are 4 subscales that address the dimensions of distress and to score, the appropriate item(s) are summed and divided by appropriate number. A mean item score of 3 or higher is considered moderate distress. burden, regimen distress, interpersonal distress and physician distress; likert scale
Measure: Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS) Time: At 0 (baseline) and 12 months (after visit 4)Description: Diabetes-related psychosocial self-efficacy as assessed using the Diabetes Empowerment Scale Short Form (DES-SF); Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
Measure: Assessment of Diabetes-Related Psychosocial Self-Efficacy Time: At 0 (baseline) and 12 months (after visit 4)Description: Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"
Measure: Self Care - Realted to Diabetes as assessed by Self-Care questionnaire Time: [At 0 (baseline) and each visit (until the end of study) - 12 months]The novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) has been discovered recently in December 2019 from wuhan city in China to spread in more than 40 countries allover the world. This disease has gain the attention of all nations after it has been stated as a pandemic by the World Health Organization (WHO) in March 12, 2020. Currently no treatment has been proved to be efficient in the treatment of infected patients by COVID-19. Natural honey has been demonstrated as potent antimicrobial in many research investigations and has been considered a good alternative for antiviral drugs for the treatment of some viral infections. The investigators aim to study the efficacy of natural honey in the treatment of COVID-19 patients in this randomized , multicenter, controlled trial, comparing honey in one arm to standard care in the other arm.
NCT04323345 COVID-19 Dietary Supplement: Natural Honey Other: Standard Care MeSH:Coronavirus Infections
Primary Outcomes
Description: Percentage of patients turned from positive to negative swaps at day 14
Measure: Rate of recovery from positive to negative swaps Time: 14 daysDescription: Number of days till no fever
Measure: Fever to normal temperature in days Time: 14 daysDescription: Number of days till lungs recovery in chest X ray or CT
Measure: Resolution of lung inflammation in CT or X ray Time: 30 daysSecondary Outcomes
Description: mortality rate in each group at 30 days
Measure: 30 days mortality rate Time: 30 daysDescription: Number of days from initiation of intervention till changing of the swap test result from positive to negative
Measure: Number of days till reaching negative swab results Time: 30 days3 Clinical Trial Evaluating Safety and Efficacy of Ivermectin and Nitazoxanide Combination as Adjuvant Therapy in COVID-19 Newly Diagnosed Egyptian Patients: A Tanta University Hope
Research Background and Rationale In December 2019, a new infectious respiratory disease emerged in Wuhan, Hubei province, China. An initial cluster of infections was linked to Huanan seafood market, potentially due to animal contact. Subsequently, human-to-human transmission occurred and the disease, now termed coronavirus disease 19 (COVID-19) rapidly spread within China and all over the world. A novel coronavirus, SARS-coronavirus 2 (SARS-CoV-2), which is closely related to SARS-CoV, was detected in patients and is believed to be the etiologic agent of the new lung disease. The causative agent of the current COVID-19 pandemic, SARS-CoV-2, is a single stranded positive sense RNA virus that is closely related to severe acute respiratory syndrome coronavirus (SARS-CoV).
NCT04360356 COVID-19 Combination Product: Ivermectin plus Nitazoxanide Other: Standard Care
Primary Outcomes
Description: COVID-19 PCR analysis
Measure: Number of Patients with COVID-19-negative PCR Time: within 10 daysSecondary Outcomes
Description: improved breaths per minute for the patients
Measure: Number of patients with improved respiratory rate Time: within 30 daysDescription: Change in PaO2 in mmHg of the patients
Measure: Number of patients with improved PaO2 Time: within 30 daysDescription: Serum IL6 in pg/mL of the patients
Measure: Number of patients with normalized Serum IL6 Time: within 30 daysDescription: Serum TNFα in pg/mL of the patients
Measure: Number of patients with normalized Serum TNFα Time: within 30 daysDescription: Serum iron in microgram/dL of the patients
Measure: Number of patients with normalized Serum iron Time: within 30 daysDescription: Serum ferritinin microgram/L of the patients
Measure: Number of patients with normalized Serum ferritin Time: within 30 daysDescription: International normalized ratio "INR" for prothrombin time of 2
Measure: Number of patients with normalized International normalized ratio "INR" for prothrombin time Time: within 30 daysDescription: CBC for lymphocyte count in cells/microliter
Measure: Number of patients with normalized complete blood count "CBC" Time: within 30 daysDescription: Mortality rate [number of dead patients/total number of treated patients]
Measure: The Mortality rate among treated patients Time: within 30 days4 Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.
NCT04409483 Covid-19 Drug: Lopinavir-Ritonavir Drug Combination Combination Product: Standard Care
Primary Outcomes
Description: Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause
Measure: Hospitalization or death Time: 15 days following randomizationSecondary Outcomes
Description: Death due to any cause
Measure: All-cause mortality Time: 15 days following randomizationDescription: Death due to any cause
Measure: All-cause mortality Time: 28 days following randomizationDescription: Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)
Measure: Time to hospitalization Time: 28 days following randomizationDescription: Total duration of hospitalization associated with desaturation (SpO2 ≤92%)
Measure: Length of hospitalization Time: 28 days following randomizationDescription: Proportion of participants admitted to an intensive care unit
Measure: Admission to intensive care Time: 28 days following randomizationDescription: Proportion of participants having an adverse event
Measure: Adverse events Time: 28 days following randomizationDescription: Proportion of participants having a serious adverse event
Measure: Serious adverse events Time: 28 days following randomization