COVID-19Phase 2NCT04583592
Camostat Efficacy vs. Placebo for Outpatient Treatment of COVID-19 (CAMELOT)
A Phase 2 study testing Camostat Mesilate in people with COVID-19, run by Sagent Pharmaceuticals Inc. at 21 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Camostat Mesilate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 21 sitesUnited States
- Study dates
- 9 Nov 2020to 31 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Visionaries Clinical Research, LLC (Site 121)
Atlanta, Georgia, 30318
Family Care Research (Site 114)
Boise, Idaho, 83704
Massachusetts General Hospital (Site 110)
Boston, Massachusetts, 02114
Synergy Healthcare, LLC (Site 124)
Bradenton, Florida, 34208
Clinical Research of Brandon, LLC (Site 123)
Brandon, Florida, 33511
Cary Research Group (Site 111)
Cary, North Carolina, 27518
Onsite Solutions (Site 118)
Charlotte, North Carolina, 28208
Cedar Crosse Research Center (Site 122)
Chicago, Illinois, 60607
Advanced Medical Trials (Site 104)
Georgetown, Texas, 78628
Reliable Clinical Research, LLC (Site 100)
Hialeah, Florida, 33012
Next Innovative Clinical Research (Site 115)
Houston, Texas, 77021
A+ Research (Site 112)
Miami, Florida, 33144
NextPhase Research Alliance at CANO HEALTH (Site 107)
Miami, Florida, 33144
Ezy Medical Research (Site 106)
Miami, Florida, 33175
Palmtree Clinical Research, Inc. (Site 125)
Palm Springs, California, 92262
Rio Grand Valley Clinical Research Institute (Site 120)
Pharr, Texas, 78577
Eminat LLC (Site 117)
Plantation, Florida, 33317
Invictus Clinical Research Group, LLC (Site 101)
Pompano Beach, Florida, 33064
STAT Research (Site 109)
Springboro, Ohio, 45066
Toledo Institute of Clinical Research, Inc.(Site 105)
Toledo, Ohio, 43617
Oakland Medical Research Center (Site 108)
Troy, Michigan, 48085
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Camostat Mesilate, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camostat MesilateDrug
Also called Camostat Mesylate, Foipan®
Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
PlaceboDrug
Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Camostat Mesilate | Experimental | Participants will receive camostat mesilate for 14 days in addition to standard of care treatment. Receives: Drug: Camostat Mesilate |
| Placebo | Placebo comparator | Participants will receive placebo for 14 days in addition to standard of care treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression at Day 28
Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
Measured: 28 days
Secondary outcomes (15)
Survival Rate
The overall survival rate (the number of randomized participants who survive up to Day 15 and Day 28).
Measured: Up to Day 15 and Day 28
Time to Fever Resolution
Time (in days) from initiation of study treatment until normalization of fever (≤ 37.2 °C oral or tympanic) and sustained for at least 3 days only assessed in participants who experienced a fever within 1 day of enrollment up to Day 28.
Measured: Up to 28 days
Resolution of Viral Shedding
Number of participants with no viral shedding (yes/no) using reverse transcriptase-polymerase chain reaction (RT-PCR) at Day 7, Day 15, and at early termination.
Measured: Day 1, Day 7 and Day 15
Rate of Adverse Events and Serious Adverse Events
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs) of any grade from randomization up to Day 28.
Measured: 28 days
Cumulative Rate of Grade 3 and 4 Adverse Events
Cumulative number of participants with grade 3 and 4 AEs from randomization up to Day 28.
Measured: 28 days
Rate of Discontinuation
Number of participants that discontinued from study due to an AE/SAE (discontinued participants will be followed up to Day 28).
Measured: 28 days
Laboratory Parameter - Platelet Count
Clinical Laboratory Value of Platelet Count at Day 1 and Day 15
Measured: Day 1 and Day 15
Laboratory Parameter - Potassium Level
Clinical laboratory value of Potassium Levels at Day 1 and Day 15
Measured: Day 1 and Day 15
Laboratory Parameter - Aspartate Aminotransferase (AST)
Clinical laboratory values of Aspartate Aminotransferase (AST) at Day 1 and Day 15
Measured: Day 1 and Day 15
Laboratory Parameter - Alanine Aminotransferase (ALT)
Clinical laboratory value of Alanine Aminotransferase (ALT) at Day 1 and Day 15
Measured: Day 1 and Day 15
Laboratory Parameter - Alkaline Phosphatase (ALP)
Clinical laboratory value of Alkaline Phosphatase (ALP) at Day 1 and Day 15
Measured: Day 1 and Day 15
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Clinical laboratory value of Gamma-Glutamyl Transferase (GGT) at Day 1 and Day 15
Measured: Day 1 and Day 15
Vital Signs - Heart Rate
Heart rate at Day 1, Day 7 and Day 15
Measured: Day 1, Day 7 and Day 15
Vital Signs - Blood Pressure
Blood pressure (BP) at Day 1, Day 7 and Day 15
Measured: Day 1, Day 7 and Day 15
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
Peripheral Capillary Oxygen Saturation (SpO2) at Day 1, Day 7 and Day 15
Measured: Day 1, Day 7 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start9 Nov 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sagent Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583592
- Sponsor's protocol ID
- NI03-CV19-001
- Status last verified
- Jan 2022
- First submitted
- 7 Oct 2020
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Camostat Mesilate for Treatment of COVID-19 in Outpatients
- ClinicalTrials.gov ID
- NCT04583592
- Acronym / sponsor ID
- NI03-CV19-001
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Sagent Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Posted 18 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camostat Mesilate | Experimental | Drug: Camostat MesilateParticipants will receive camostat mesilate for 14 days in addition to standard of care treatment. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo for 14 days in addition to standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camostat MesilateAlso: Camostat Mesylate, Foipan®Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days. | Drug | Camostat Mesilate |
| PlaceboPlacebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days. | Drug | Placebo |
Primary outcome
Disease Progression at Day 28
Time frame: 28 days
Disease progression will be defined as the number of participants requiring hospitalization (including emergency room visit) or who die due to any cause within 28 days of randomization.
15 secondary outcomes
Survival Rate
Time frame: Up to Day 15 and Day 28
Time to Fever Resolution
Time frame: Up to 28 days
Resolution of Viral Shedding
Time frame: Day 1, Day 7 and Day 15
Rate of Adverse Events and Serious Adverse Events
Time frame: 28 days
Cumulative Rate of Grade 3 and 4 Adverse Events
Time frame: 28 days
Rate of Discontinuation
Time frame: 28 days
Laboratory Parameter - Platelet Count
Time frame: Day 1 and Day 15
Laboratory Parameter - Potassium Level
Time frame: Day 1 and Day 15
Laboratory Parameter - Aspartate Aminotransferase (AST)
Time frame: Day 1 and Day 15
Laboratory Parameter - Alanine Aminotransferase (ALT)
Time frame: Day 1 and Day 15
Laboratory Parameter - Alkaline Phosphatase (ALP)
Time frame: Day 1 and Day 15
Laboratory Parameter - Gamma-Glutamyl Transferase (GGT)
Time frame: Day 1 and Day 15
Vital Signs - Heart Rate
Time frame: Day 1, Day 7 and Day 15
Vital Signs - Blood Pressure
Time frame: Day 1, Day 7 and Day 15
Vital Signs - Peripheral Capillary Oxygen Saturation (SpO2)
Time frame: Day 1, Day 7 and Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camostat Mesilate in people with COVID-19, run by Sagent Pharmaceuticals Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Progression at Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.