Table 2.

Comparison of the study design disclosed by Prevent Senior with the records in ClinicalTrials.gov and Plataforma Brasil.

	Documento Prevent Senior	ClinicalTrials.gov	Plataforma Brasil
Title of the document	Empirical treatment of suspected cases of COVID‐19 with hydroxychloroquine and azithromycin. Follow‐up was done by telemedicine	Open Label, Multicentric, Non‐Randomized, Exploratory Clinical Trial to Assess the Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Mild Acute Respiratory Syndrome (COVID‐19) Caused by SARS‐CoV‐2 Virus	A concept, open‐label, non‐randomized clinical trial to evaluate the efficacy and safety of oral administration of hydroxychloroquine in combination with azithromycin in the treatment of mild acute respiratory illness (COVID‐19) caused by SARS‐CoV‐2 virus.
		Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients with mild COVID‐19
Principal Investigator/Corresponding Author	Rodrigo Barbosa Esper	Rafael Souza	Rafael Souza da Silva
Date research begun	March 26, 2020	April 20, 2020	April 6, 2020
Date research project ended	April 4, 2020	July 31, 2020	June 28, 2020
Objective	To assess whether the empirical prescription of hydroxychloroquine and azithromycin to patients with suspected COVID‐19 decreases the need for hospitalization.	To demonstrate a decrease in hospital related complications among ambulatory patients with mild COVID‐19 by treating them with HCQ and AZ on top of standard care, compared to patients who receive standard care only.
Description of the study	A telemedicine team evaluated suspected COVID‐19 outpatients with flu‐like symptoms, if no contraindications were detected, treatment with hydroxychloroquine and azithromycin was prescribed after obtaining consent from subjects. Using telemedicine, patients were monitored daily […] until the fifth day of symptoms, after that, patients were contacted twice a day (sic*) until the fourteenth day of symptoms. Hydroxychloroquine and azithromycin were delivered to the home of the patients who who consented to home visits and to the use of medication. *Probably should read twice a week.	Exploratory study to evaluate the efficacy of hydroxychloroquine and azithromycin to treat mild ambulatory COVID‐19 patients. Ambulatory patients who on day 3 have symptoms and a confirmed diagnosis of COVID‐19 will receive the treatment. Study Type: Interventional. Primary Purpose: Treatment. Study Phase: Early Phase 1. Interventional Study Model: Single Group Assignment. Number of Arms: 1. Masking: None (Open Label). Allocation: N/A. Enrollment: 200 [Anticipated]	see above (Title cell)
Intervention group	Outpatients with persistent flu‐like symptoms (suspected COVID‐ 19 infection), persisting for equal of longer than 2 days, were first evaluated by the telemedicine team or by the emergency physician. Patients received hydroxychloroquine 800 mg on the first day and 400 mg for 6 days, and azithromycin 500 mg once daily for five days. Patients in the treatment group consented to the treatment with hydroxychloroquine plus azithromycin.	Ambulatory patients on day 3 of symptoms and with confirmed diagnosis of COVID‐19 will receive the treatment. All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D7) for 7 days, and AZ 500 mg per day for 5 days.
Control group	The control group was composed of patients who refused and did not sign the informed consent to receive hydroxychloroquine and azithromycin.	Patients who do not fulfill the inclusion/exclusion criteria or who are not willing to participate in the study will be invited to consent to use their data as part of the “control” group.
Outcome Measures	To evaluate whether the empirical prescription of Hydroxychloroquine plus Azithromycin to outpatients decreases the need for hospitalization. To evaluate the difference in the rate of hospitalization among patients treated before and after the seventh day of symptoms. The main hospitalization admission criteria were:	Primary Change in Clinical Condition [Time Frame: 28 days] Ordinal scale (7 points ordinal scale that measures illness severity over time)
	Worsening general condition Oxygen Saturation < 90%
	Breathing pattern was evaluated during videoconference It was considered that the patient had dyspnea when s/he referred “a subjective experience of breathing discomfort consisting of qualitatively distinct sensations that varied in intensity”. The improvement in dyspnea during follow‐up was defined as the total improvement in dyspnea symptoms reported by the patient. The swab diagnostic test was not mandatory and chest computed tomography was performed on selected patients according to medical judgment. Lung injury criteria for COVID‐19 were determined based on tomography scans displaying the presence of opacities in multiple lung lobes with bilateral predominance and peripheral localization (which may evolve to the central region). All patients were followed daily by telemedicine consultations until the fifth day of symptoms, after that, patients were contacted twice a day until the fourteenth day of initial symptoms.
		Secondary 1. Hospitalization 2.Time for normalization of body temperature 3.Time for normalization of respiratory rate 4. Time for cough relief 5. Rate of mortality within 28‐days 6. Change in Clinical Condition related to comorbidity Time Frame: 28 days
Number of participants	636 (412 experimental group, 224 control group)	200	200
Inclusion criteria	Patient over 18 years old and flu‐like persistent symptoms > 3 days, with a probable diagnosis of COVID‐19 and no immediate indication for hospitalization.	1. Informed consent from patient or legal representative. 2. Male or female, and: a. aged ≥ 70 years; or aged < 70 ≥ 18 with associated risk factors (chronic obstructive pulmonary disease; heart failure, immunosuppressed, obesity [BMI ≥ 35] uncontrolled diabetes and uncontrolled systemic arterial hypertension) 3. One or more mild symptoms characteristic of COVID‐19 for 3 days, such as fever, cough, and signs of respiratory distress, which did not require hospitalization.
Exclusion criteria	1. Severe related retinopathy 2. Severe liver disease 3. Myasthenia Gravis 4. Known QT enlargement 5. Pregnant 6. Severe renal failure	1. Participation in another RCT in the last 12 months 2. Known allergy to HCQ or chloroquine 3. Any contraindication to HCQ or AZ, including retinopathy and prolonged QT, 4. Severely reduced LV function 5. Severely reduced renal function 6. Pregnant or breastfeeding Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Consent	The consent form was electronically sent to the patient and signed online, during telemedicine call or presently when the first evaluation was done in the emergency room. Control group consisted of patients that refused and did not sign the informed consent. All patients were informed that the efficiency (sic) of AZ and HQC in treating COVID‐19 remains to be determined. They were also informed about the safety profile of the drugs and their potential side effects.

Source: Produced by the authors using the referenced documents.117