Covid19
Conditions
Brief summary
This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.
Detailed description
This is an open-label, non-randomized study to evaluate anti-malarial/anti-infective single-agents and combination therapies for patients with confirmed COVID-19 infection requiring therapy as determined by risk factors for complication (age, comorbid illness) or the presence of respiratory compromise. The first combination to be evaluated is atovaquone/azithromycin. Other combinations may be added to the study at future amendments as information of potential benefit arises. The first part of the study will enroll 25 evaluable male and female patients 18 years of age or older with confirmed COVID-19 infection.
Interventions
DRUGAtovaquone/Azithromycin
Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
Sponsors
HonorHealth Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female patients age 18 years or older * COVID-19 confirmed positive test results * High risk for complications including with Medium (5-6) or High (More than or equal to 7) NEWS score * Hematology criteria: ANC \>500 cells/mcl, HGB \>9 g/dl, Platelet count \>75,000/mcl * Metabolic criteria: Serum creatinine \<2.0 mg/dl or calculated creatinine clearance (using Cockcroft-Gault) \>30 ml/min, AST/ALT \<5x ULN AND Total Bilirubin WNL (for patients with Gilbert's disease, direct bilirubin \<ULN)
Exclusion criteria
* COVID-19 negative test result * Inability to adhere to study protocol requirements * Inability to provide informed consent * Other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study * Pregnant and breastfeeding individuals * QTc interval greater than 470 msecs at baseline * History of hypersensitivity to atovaquone and/or azithromycin. * History of known intolerance to atovaquone and/or azithromycin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virology Cure Rate | 10 days | Virology cure rate defined as the percentage of patients who achieved undetectable COVID-19 viral load via serology testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Gastrointestinal Adverse Events | 47 days | Measured incidence of diarrhea, vomiting, nausea, and constipation. |
| Cardiac Toxicity | 10 days | Cardiac toxicity measured by 12-lead electrocardiogram (ECG) daily if QTc \>500 msec. The number of QTc \>500 msec events after beginning study regimen is reported here. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael Gordon, MD
HonorHealth Research Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
None listed