Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04583592

Run by

Sagent Pharmaceuticals Inc.

People needed

295

Starts

2020-11-09

Expected to finish

2021-03-31

Last updated by the study team

2022-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults willing and able to provide informed consent before performing study procedures
• Adults ≥18 years of age at 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 (eg, 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 prior to 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

You may not qualify if…

• 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 (eg, 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)

Where it is running

• Palmtree Clinical Research, Inc. (Site 125) — Palm Springs, California, United States
• Synergy Healthcare, LLC (Site 124) — Bradenton, Florida, United States
• Clinical Research of Brandon, LLC (Site 123) — Brandon, Florida, United States
• Reliable Clinical Research, LLC (Site 100) — Hialeah, Florida, United States
• A+ Research (Site 112) — Miami, Florida, United States
• NextPhase Research Alliance at CANO HEALTH (Site 107) — Miami, Florida, United States
• Ezy Medical Research (Site 106) — Miami, Florida, United States
• Eminat LLC (Site 117) — Plantation, Florida, United States
• Invictus Clinical Research Group, LLC (Site 101) — Pompano Beach, Florida, United States
• Visionaries Clinical Research, LLC (Site 121) — Atlanta, Georgia, United States
• Family Care Research (Site 114) — Boise, Idaho, United States
• Cedar Crosse Research Center (Site 122) — Chicago, Illinois, United States
• Massachusetts General Hospital (Site 110) — Boston, Massachusetts, United States
• Oakland Medical Research Center (Site 108) — Troy, Michigan, United States
• Cary Research Group (Site 111) — Cary, North Carolina, United States
• Onsite Solutions (Site 118) — Charlotte, North Carolina, United States
• STAT Research (Site 109) — Springboro, Ohio, United States
• Toledo Institute of Clinical Research, Inc.(Site 105) — Toledo, Ohio, United States
• Advanced Medical Trials (Site 104) — Georgetown, Texas, United States
• Next Innovative Clinical Research (Site 115) — Houston, Texas, United States
• Rio Grand Valley Clinical Research Institute (Site 120) — Pharr, Texas, United States

Full record on ClinicalTrials.gov

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