Study to Evaluate the Effect of a Probiotic in COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04390477|
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Coronavirus Infection||Dietary Supplement: Probiotic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Random numbers table. One branch placebo and other one no intervention|
|Official Title:||The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection|
|Actual Study Start Date :||May 4, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||September 2021|
1 pill od containing 1x10E9 cfu of the probiotic
Dietary Supplement: Probiotic
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.
No Intervention: Control
- Cases with discharge to ICU. [ Time Frame: 30-days ]Percentage of patients with discharge to ICU.
- Patients with home discharge. [ Time Frame: 30-days ]Percentage of patients with home discharge.
- Mortality. [ Time Frame: 30-days ]Percentage of deaths.
- Treatment safety assessed by number of adverse events. [ Time Frame: 30-days ]Number of adverse events that occur during the treatment period, attributable or not to the intervention product.
- New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients. [ Time Frame: 30-days ]Number of new cases of positive SARS-Cov-2 infection by PCR analysis.
- Patients with negative PCR result for SARS-CoV-2 infection. [ Time Frame: 30-days ]Percentage of patients with negative PCR for SARS-CoV-2.
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): NCT04390477
|Contact: Laura Navarroemail@example.com|
|Hospital Universitario del Vinalopó||Recruiting|
|Elche, Alicante, Spain, 03293|
|Contact: Vicente Navarro 968278800 firstname.lastname@example.org|
|Principal Investigator: Maria Isabel Perez-Soto|
|Hospital Universitario de Torrevieja||Recruiting|
|Torrevieja, Alicante, Spain, 03198|
|Contact: Vicente Navarro 965721200 email@example.com|
|Principal Investigator: Maykel Ayo-González|
|Principal Investigator:||Vicente Navarro||Hospital universitario del Vinalopo, Elche, Spain|