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NCT04353284

Camostat Mesylate in COVID-19 Outpatients

Completed Phase 2 Results posted Last updated 24 March 2022
What this trial tests

Phase 2 trial testing Camostat Mesilate in COVID-19 in 70 participants. Completed in 22 April 2021.

Timeline
9 June 2020
Primary endpoint
3 March 2021
22 April 2021

Quick facts

Lead sponsorYale University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment70
Start date9 June 2020
Primary completion3 March 2021
Estimated completion22 April 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in SARS-COV-2 Viral Load Primary · 5 days (day 0 to day 4)

To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 4 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

Day 0
GroupValue95% CI
Camostat Mesylate6.56.0 – 6.9
Placebo6.56.0 – 6.9
Day 4
GroupValue95% CI
Camostat Mesylate4.43.8 – 5.1
Placebo3.73.0 – 4.3
Change (Day 4 - Day 0)
GroupValue95% CI
Camostat Mesylate-2.0-2.6 – -1.5
Placebo-2.8-3.3 – -2.2
Change in SARS-COV-2 Viral Load Secondary · 3 days (day 0 to day 2)

To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 2 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

GroupValue95% CI
Camostat Mesylate-1.2-1.8 – -0.6
Placebo-1.3-1.8 – -0.7
Change in SARS-COV-2 Viral Load Secondary · 7 days (day 0 to day 6)

To determine whether camostat mesylate reduces SARS-COV-2 viral load (N Gene) in early COVID-19 disease, change from day 0 to day 6 in respiratory (oropharyngeal swab RT-PCR) log10 viral load will be assessed.

GroupValue95% CI
Camostat Mesylate-3.6-4.5 – -2.8
Placebo-3.9-4.7 – -3.0
Number of Participants With Change in Positive COVID-19 Status Secondary · 7 days

Change in risk for a positive COVID-19 test at day 6 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.

Nasopharyngeal Swab Samples
GroupValue95% CI
Camostat Mesylate17
Placebo18
Camostat Mesylate5
Placebo7
Saliva RT-PCR
GroupValue95% CI
Camostat Mesylate14
Placebo21
Camostat Mesylate8
Placebo4
Number of Participants With Change in Positive COVID-19 Status Secondary · 14 days

Change in risk for a positive COVID-19 test at day 13 after enrollment (day 0) will be assessed by analyzing the proportion of positive cases in each study arm.

Nasopharyngeal Swab Samples
GroupValue95% CI
Camostat Mesylate21
Placebo12
Camostat Mesylate12
Placebo21
Saliva RT-PCR
GroupValue95% CI
Camostat Mesylate16
Placebo14
Camostat Mesylate17
Placebo18
Change in Positive COVID-19 Status Secondary · 28 days

Number of Participants With Change in Positive COVID-19 Status

Nasopharyngeal Swab Samples
GroupValue95% CI
Camostat Mesylate5
Placebo1
Camostat Mesylate27
Placebo33
Saliva RT-PCR
GroupValue95% CI
Camostat Mesylate5
Placebo6
Camostat Mesylate27
Placebo28
Change in COVID-19 Symptom Severity Secondary · Day 0 to Day 6

Change of COVID-19 symptom severity from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 =

Day 0
GroupValue95% CI
Camostat Mesylate31.527.3 – 35.8
Placebo31.527.3 – 35.8
Day 6
GroupValue95% CI
Camostat Mesylate12.47.3 – 17.5
Placebo19.114.0 – 24.1
Change in COVID-19 Symptom Severity Secondary · Day 0 to Day 13

Change of COVID-19 symptom severity from day 0 to day 14 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0

Day 0
GroupValue95% CI
Camostat Mesylate31.527.3 – 35.8
Placebo31.527.3 – 35.8
Day 13
GroupValue95% CI
Camostat Mesylate7.82.5 – 13.2
Placebo9.94.8 – 15.1
Change in COVID-19 Symptom Frequency Secondary · Day 0 to Day 6

Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no freq

Day 0
GroupValue95% CI
Camostat Mesylate5.95.0 – 6.8
Placebo5.95.0 – 6.8
Day 6
GroupValue95% CI
Camostat Mesylate5.03.9 – 6.2
Placebo4.13.0 – 5.2
Change in COVID-19 Symptom Frequency Secondary · Day 0 to Day 13

Change of COVID-19 symptom frequency score from day 0 to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 34-38 measure the frequency of specific daily symptoms and are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 = 0 times and 4 = 4 times or more. These items are summed to score the frequency of symptoms- where the highest score (20) indicates the greatest burden of symptom frequency, the lowest possible score (0) indicates no freq

Day 0
GroupValue95% CI
Camostat Mesylate5.95.0 – 6.8
Placebo5.95.0 – 6.8
Day 13
GroupValue95% CI
Camostat Mesylate2.71.5 – 4.0
Placebo2.10.9 – 3.2
Change in Body Temperature Secondary · 7 days (Day 0 to Day 6)

Change of COVID-19 symptom score from baseline to day 6 will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0 =

Day 0
GroupValue95% CI
Camostat Mesylate98.5± 0.8
Placebo98.3± 0.8
Day 6
GroupValue95% CI
Camostat Mesylate98.0± 1.0
Placebo98.1± 0.7
Change in Body Temperature Secondary · 28 days

Change of COVID-19 symptom score from baseline to 28 days will be assessed with the COVID-19 daily self score tool. Adapted from the FLU-PRO instrument, it consists of 39 items that are answered daily. Items 1-33 are Likert scale questions (rated 0-4) where 0 = not at all and 4 = very much. These items are summed to score the severity of symptoms- where a total score of 132 would indicate the greatest severity of symptoms and a score of 0 would indicate no severity of symptoms. Items 34-38 are also Likert scale questions (rated 0-4) that measure the frequency of specific daily symptoms where 0

Day 0
GroupValue95% CI
Camostat Mesylate98.5± 0.8
Placebo98.3± 0.8
Day 27
GroupValue95% CI
Camostat Mesylate97.8± 0.5
Placebo97.7± 0.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 28 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Camostat Mesylate
Serious: 2/35 (6%)
Deaths: 0/35
Placebo
Serious: 0/35 (0%)
Deaths: 0/35

Serious adverse events (2 terms)

ReactionSystemCamostat MesylatePlacebo
Shortness of BreathRespiratory, thoracic and mediastinal disorders——
Respiratory InfectionRespiratory, thoracic and mediastinal disorders——
Other adverse events (1 terms — click to expand)

ReactionSystemCamostat MesylatePlacebo
PruritusSkin and subcutaneous tissue disorders——

Most-reported serious reactions: Shortness of Breath, Respiratory Infection.

Data from ClinicalTrials.gov NCT04353284 adverse events section.

Sponsor's own description

The rationale of the present clinical trial is that an orally available drug given to outpatients that could reduce the viral burden in the upper respiratory tract could forestall complications of SARS-CoV-2 infection and reduce transmission from one infected individual to another.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Structural and functional properties of SARS-CoV-2 spike protein: potential antivirus drug development for COVID-19.
    Huang Y, Yang C, Xu XF, Xu W, et al · · 2020 · cited 1584× · PMID 32747721 · DOI 10.1038/s41401-020-0485-4
  2. Camostat mesylate inhibits SARS-CoV-2 activation by TMPRSS2-related proteases and its metabolite GBPA exerts antiviral activity.
    Hoffmann M, Hofmann-Winkler H, Smith JC, Krüger N, et al · · 2021 · cited 317× · PMID 33676899 · DOI 10.1016/j.ebiom.2021.103255
  3. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
    Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
  4. Cathepsin L-selective inhibitors: A potentially promising treatment for COVID-19 patients.
    Liu T, Luo S, Libby P, Shi GP. · · 2020 · cited 211× · PMID 32470470 · DOI 10.1016/j.pharmthera.2020.107587
  5. The emergence of COVID-19 as a global pandemic: Understanding the epidemiology, immune response and potential therapeutic targets of SARS-CoV-2.
    Muralidar S, Ambi SV, Sekaran S, Krishnan UM. · · 2020 · cited 184× · PMID 32971147 · DOI 10.1016/j.biochi.2020.09.018
  6. Targeting transcriptional regulation of SARS-CoV-2 entry factors <i>ACE2</i> and <i>TMPRSS2</i>.
    Qiao Y, Wang XM, Mannan R, Pitchiaya S, et al · · 2021 · cited 155× · PMID 33310900 · DOI 10.1073/pnas.2021450118
  7. Sex differences in SARS-CoV-2 infection rates and the potential link to prostate cancer.
    Chakravarty D, Nair SS, Hammouda N, Ratnani P, et al · · 2020 · cited 114× · PMID 32641750 · DOI 10.1038/s42003-020-1088-9
  8. The TMPRSS2 Inhibitor Nafamostat Reduces SARS-CoV-2 Pulmonary Infection in Mouse Models of COVID-19.
    Li K, Meyerholz DK, Bartlett JA, McCray PB. · · 2021 · cited 113× · PMID 34340553 · DOI 10.1128/mbio.00970-21

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