Covid-19 Living Data

Trial NCT04390022
Publication SAINT - Chaccour C, EClinicalMedicine (2021) (published paper)
Dates: 2020-07-31 to 2020-09-11
Funding: Mixed (ISGlobal; University of Navarra. Unitaid; Spanish Ministry of Science and Innovation; Generalitat de Catalunya; Idipharma SL (placebo donation))
Conflict of interest: No

Methods
	RCT Blinding:
	Location : Single center / Spain Follow-up duration (days): 28
Inclusion criteria	Patients diagnosed with COVID-19 in the emergency room of the Clinica Universidad de Navarra with a positive SARS-CoV-2 PCR Residents of the Pamplona basin ("Cuenca de Pamplona") Aged 18 to 59 years Negative pregnancy test for women of child bearing age The patient or his/her representative, have given consent to participate in the study The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation). Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study)
Exclusion criteria	Known history of Ivermectin allergy Hypersensitivity to any component of Stromectol® COVID-19 Pneumonia (Diagnosed by the attending physician, Identified in a chest X-ray) Fever or cough present for more than 48 hours Positive IgG against SARS-CoV-2 by rapid test Age under 18 or over 60 years The following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator): Immunosuppression, Chronic Obstructive Pulmonary Disease, Diabetes, Hypertension, Obesity, Acute or chronic renal failure, History of coronary disease, History of cerebrovascular disease, Current neoplasm Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan) Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.
Interventions
	Treatment Ivermectin 400 mcg/kg orally once off.
	Control Placebo
Participants
	Randomized participants : Ivermectin=12 Placebo=12
	Characteristics of participants N= 24 Mean age : NR 12 males Severity : Mild: n= 24/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment
	In the report Proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day 7 post-treatment
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the supplementary appendices, the study registry, protocol and data analysis plan were used in data extraction and risk of bias assessment. There were no substantive differences between the pre-print article and the trial registry, study protocol and statistical analysis plan in population, procedures, interventions or outcomes. The study achieved its stated sample size. Quote: "The placebo tablets did not match ivermectin in appearance, therefore, in order for the clinical team to remain blinded, treatment was administered under direct supervision by a nurse not participating in patient´s care. There was slow recruitment due to a sharp reduction in local transmission for 10 weeks after the lockdown of March-April 2020, the protocol was amended on September 2nd to extend the inclusion criteria from 48 to a maximum of 72 hours of cough or fever." This study was updated on January 28th, 2021 after publication of the study report.