Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat (NICCAM)
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|ClinicalTrials.gov Identifier: NCT04750759|
Recruitment Status : Suspended (pandemic sitation)
First Posted : February 11, 2021
Last Update Posted : August 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Niclosamide + Camostat Other: Placebo||Phase 2|
Niclosamide is an approved drug for the treatment of intestinal worm infections that can potentially induce the process of autophagy and thus significantly limit viral replication in cells.
Camostat is approved in Japan for the treatment of chronic pancreatitis and reflux esophagitis. It has been shown to effectively block viral replication in a SARS-CoV-2 animal model.
Since the mechanisms of actions are different, it was hypothesized that a combination of both substances might have an additive or even synergistic effect in the treatment of patients with COVID-19.
This study is designed to investigate the safety, tolerability and preliminary efficacy of the treatment combination niclosamide and camostat in mild and moderately affected COVID-19 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Single Blind, Placebo-controlled, Multiple Dose, Parallel-arm Study to Investigate the Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat to Treat COVID-19 ("NICCAM")|
|Actual Study Start Date :||February 3, 2021|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
Active Comparator: Niclosamide + Camostat
Patients will receive the combination of niclosamide chewing tablets (2000 mg, once daily) and camostat tablets (600 mg, 4-times daily) over a period of 7 days.
Drug: Niclosamide + Camostat
Niclosamide will be applied in combination with camostat.
Placebo Comparator: Placebo
Patients will receive placebo orally over a period of 7 days.
Placebo to interventional drug
- Treatment emergent number of Adverse Events [ Time Frame: 21 days ]All pathological and clinically significant findings in physical examinations, vital signs, 12-lead ECGs, oxygen saturation and safety lab including coagulation will be documented as adverse events. Adverse events will be reported on the basis of CTCAE v5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750759
|Charité Research Organisation GmbH|
|Berlin, Germany, 10117|
|Principal Investigator:||Martin Witzenrath, Prof.||Charite University, Berlin, Germany|