SARS-CoV-2
Conditions
Interventions
Upamostat Placebo
Sponsors
FHI Clinical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Population A 1. Age = 18 years 2. Positive molecular or antigen diagnostic test for SARS-CoV-2 at study enrollment or within = 5 days prior to enrollment 3. Presence of two or more Screening Symptoms with at least two symptoms classified as moderate to severe (and/or = 2 on the frequency questions or loss of taste/smell questions) at the time of enrollment: For participants who have preexisting conditions causing mild or moderate symptoms listed on the Screening Symptom Questionnaire, there must be an increase of at least one severity level for that symptom at enrollment (For example, prior to illness participant routinely experienced headaches rated as moderate severity, now rating headache as severe at enrollment). Supplement 3 Screening Symptoms: stuffy or runny nose, hoarse voice, sore throat, difficulty breathing, cough, fatigue (low energy or tiredness), muscle or body aches, headache, fever (documented temperature > 38° C [100.4° F]) or subjective fever, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, loss of smell, loss of taste. 4. Symptom onset = 5 days prior to enrollment UPAMOSTAT - ADDITIONAL INCLUSION CRITERIA Women of childbearing potential must agree to use an effective contraceptive method upon enrollment in the study through 8 weeks after the last dose of the investigational product. This would include oral contraceptives, implanted contraceptives, intrauterine devices, and barrier methods. o A woman is considered of childbearing potential unless post-menopausal (subject is at least 50 years old and has history of =2 years without menses without other known or suspected cause), or permanently surgically sterilized. o Participants not of reproductive potential are eligible without requiring the use of a contraceptive method. Participant-reported history is acceptable documentation of surgical sterilization and menopause.
Exclusion criteria
Exclusion criteria: 1. Hospital admission at the time of enrollment 2. Hospitalization will be defined as requiring medical care not available in an outpatient setting for greater than 24 hours 3. Hospitalization for isolation or quarantine requirements or for social reasons will NOT constitute an exclusion criterion 4. Laboratory confirmed SARS-CoV-2 infection 6 to 90 days prior to enrollment 5. Oxygen saturation 450 msec o Pathological Q-waves (defined as Q-wave > 40 msec or depth > 0 o Evidence of ventricular pre-excitation o ECG/EKG evidence of complete LBBB, RBBB, incomplete LBBB, in complete RBBB o Evidence of second- or third-degree heart block o Intraventricular conduction delay with QRS duration > 120 msec o Bradycardia as defined by sinus rate< 50 bpm o Personal or family history of long QT syndrome o Personal history of cardiac disease, symptomatic/asymptomatic arrhythmia o Syncopal episodes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early Treatment: Time to sustained alleviation or resolution of COVID-19 symptoms Defined as the number of days from randomization within a PSA to the first day the participant reports all symptoms as mild or none for at least 3 consecutive days. Symptoms will be assessed via completion of a Screening Symptom Questionnaire at Enrolment and then a Daily Follow Up Symptom Questionnaire ;Post-Exposure Prophylaxis: Incidence of symptomatic COVID-19 by Day 14. Defined as a positive SARS-CoV-2 RT-PCR test and the presence of at least one COVID-19 symptom. COVID-19 symptoms will be ascertained using the Daily Follow Up Symptom Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Early Treatment: Number and proportion of all cause hospitalizations;Early Treatment Upamostat Arm: Change in overall COVID-19 symptom severity score A mixed model repeated measure (MMRM) model will be used to model the symptom severity score at each day using the baseline symptom score, participant, day, and treatment by day as covariates.;Early Treatment Upamostat Arm: Proportion of participants in each treatment group developing new COVID-19 symptoms rated as severe A Cox proportional hazards model will be used to analyse development of new severe symptoms;Early Treatment Upamostat Arm: Proportion of participants who report: - Return to usual state of health - Return to usual activities A Cox proportional hazards model will be used to analyze the time to: - return to usual state of health - return to usual activities;Early Treatment Upamostat Arm: Proportion of participants hospitalized for COVID-19 Adjudicated prior to study unblinding;Early Treatment Upamostat Arm: Number and proportion of participants hospitalized (all cause);Early Treatment Upamostat Arm: Number and proportion of participant deaths (all cause);Early Treatment Upamostat Arm: Comparison of active and placebo treatment groups in time to negative PCR Time to negative RT-PCR will be defined as the time of the first of two consecutive readings below the lower limit of detection. A Cox proportional hazards model will be used to analyze the time to negative PCR;Other Pre-specified Outcome Measures: Early Treatment Upamostat Arm: Incidence of Serious Adverse Events (SAE);Other Pre-specified Outcome Measures: Early Treatment Upamostat Arm: Incidence of AEs causing IP discontinuation;Other Pre-specified Outcome Measures: Early Treatment Upamostat Arm: Incidence of all-cause IP discontinuation or interruption;Other Pre-specified Outcome Measures: Early Treatment Upamostat Arm: Comparison between active and placebo treatment groups in proportion of all and greater than or equal to grade 3 adverse events. | — |
Countries
South Africa, Uganda
Contacts
Public ContactZaheer Hoosain
Principal Investigator JOSHA Research
Outcome results
None listed