COVID-19 Clinical Research Studies
In our Visionaries clinic, a clinical study is being conducted on the impact of Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
This is a randomized, double-blind, placebo-controlled study of camostat mesilate in ambulatory patients with confirmed COVID-19 with at least one risk factor for severe illness.
Detailed Description
Participants will be randomized in a 2:1 ratio of camostat:placebo. Approximately 300 participants are planned to be enrolled (200 participants to camostat mesilate and 100 participants to placebo). Participants will be treated with camostat mesilate 200 mg or placebo drug orally 4 times a day for 14 days, and receive local standard of care (SOC) in addition to study drug. Participants will be followed until Day 28. Participants will be seen in the clinic for assessments, blood draws, and mid-turbinate nasal samples on Screening/Day 1, Day 7, Day 15 and early termination.
Study Design
- Study Type — Interventional (Clinical Trial).
- Actual Enrollment — 295 participants.
- Allocation — Randomized.
- Actual Study Start Date — November 9, 2020.
- Actual Primary Completion Date — March 31, 2021.
- Actual Study Completion Date — March 31, 2021.
Recruitment Status — Completed
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies
Criteria
- Ages Eligible for Study —18 Years and older (Adult, Older Adult).
- Sexes Eligible for Study — All.
- Accepts Healthy Volunteers — No.
Inclusion Criteria
- Adults willing and able to provide informed consent before performing study procedures
- Adults ≥18 years of age at the time of informed consent
- Participants must have written notification of laboratory-confirmed COVID-19 infection performed prior to screening, at a local laboratory by RT-PCR or other commercial or public health assay in any specimen; and participants must be randomized within 72 hours of receiving the above notification of laboratory-confirmed COVID-19
- Have a mild or moderate form of COVID-19 defined as SpO2 > 94% at screening
- Participants must have at least 1 of the following risk factors for severe illness
- Aged 65 years or older
- Hypertension
- Diabetes mellitus
- Chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (e.g., idiopathic pulmonary fibrosis)
- Chronic cardiac conditions, including coronary artery disease (CAD), heart failure, congenital heart disease, cardiomyopathy
- Severe obesity (body mass index [BMI] ≥ 40 kg/m^2)
- Chronic liver disease, including cirrhosis
- Must agree not to enroll in another study of an investigational agent or take any other drug that has been granted Emergency Use Authorization before completion of Day 28
- If women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception during the study and for 90 days after receiving the last dose of study drug
Exclusion Criteria
- Physician makes a decision that trial involvement is not in participants' best interest or has any condition that does not allow the protocol to be followed safely.
- Known severe liver disease (e.g., Child-Pugh score > 12, AST >5 times upper limit)
- SaO2/SPO2 ≤94% on room air condition, or the Pa02/Fi02 ratio < 300 mgHg
- Known allergic reaction to camostat mesilate or one of its excipients
- Known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m^2) or receiving dialysis
- Pregnant or breastfeeding, or positive pregnancy test in a predose examination
- Receipt of any experimental treatment for COVID-19, including agents with demonstrated or possible direct-acting antiviral activity, including, but not limited to, remdesivir, hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or ivermectin, within the 30 days prior to the time of the screening evaluation. No off-label use of a drug for COVID 19 is allowed.
- History of human immunodeficiency virus infection on highly active antiretroviral therapy (HAART).
Data taken from the site clinicaltrials.gov
In our Visionaries clinic, a clinical study is being conducted on the impact of VIR-7831 for the Early Treatment of COVID-19 in Outpatients (COMET-ICE).
This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.
Study Design
- Study Type — Interventional (Clinical Trial).
- Estimated Enrollment — 1360 participants.
- Allocation — Randomized.
- Actual Study Start Date — August 27, 2020.
- Estimated Primary Completion Date — March 2021.
- Estimated Study Completion Date — July 2021.
Recruitment Status — Active, not recruiting
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies
Criteria
- Ages Eligible for Study — 18 Years and older (Adult, Older Adult).
- Sexes Eligible for Study — All.
- Accepts Healthy Volunteers — No.
Inclusion Criteria
- Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old.
- Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms.
Exclusion Criteria
- Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours.
- Symptoms consistent with severe COVID-19.
- Participants who, in the judgement of the investigator are likely to die in the next 7 days.
- Severely immunocompromised participants.
Data taken from the site clinicaltrials.gov
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