A randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ivermectin in asymptomatic and mild severity COVID-19 patients

Abstract: CONFIDENTIAL 1. Clinical Study Report IVM-2021-01 Synopsis Name of Sponsor/Company: Name of Active Ingredient: MEDITOP Gyógyszeripari Kft. Ivermectin Title of Study: A randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ivermectin in asymptomatic and mild severity COVID-19 patients Investigators and Study centre(s):          A/ Dr. Botond Lakatos Dél-pesti Centrumkórház B/ Dr. Gabriella Temesi Országos Korányi Pulmonológiai Intézet (Inactive site) D/ Dr. István Várkonyi Debreceni Egyetem Kenézy Gyula Egyetemi Kórház E/ Dr Eleonóra Harcsa Markhot Ferenc Oktatókórház és Rendelőintézet (Inactive site) F/ Dr Judit Simon Családgyógyász Kft. (Inactive site) G/ Dr Albert Papp Trial Pharma Kft. Gyula (Inactive site) H/ Dr Attila Dombi Trial Pharma Kft. Békéscsaba (Inactive site) I/ Dr Erika Unger Trial Pharma Kft. Csorna (Inactive site) J/ Dr Enikő Deák Deákpraxis Kft / Trialpharma Kft., Kübekháza Háziorvosi Rendelő (Site was approved but not opened) Studied period: Phase of development: First patient first visit: 26/Mar/2021 Phase II Last patient last visit: 05/Jul/2021 Objectives: The objective of the study was to evaluate the safety and efficacy of per os ivermectin administration in the treatment of asymptomatic and mild severity SARS-CoV-2 infected patients.    Primary Objective: To assess the efficacy of per os ivermectin administration in asymptomatic and mild severity SARS-CoV-2 infected patients on reduction of virus load. Secondary Efficacy Objective: Assessment of efficacy of per os ivermectin administration in mild severity SARS-CoV-2 infected patients on healing course and post-COVID symptoms. Safety Objective: Assessment of safety of per os ivermectin administration in asymptomatic and mild severity SARS-CoV-2 infected patients. Endpoints: Primary Endpoint: MEDITOP v1.0 26/Jun/2023 2 CONFIDENTIAL  Clinical Study Report IVM-2021-01 [PRIM] Percentage of SARS-CoV-2 virus copy number at Day 7 compared to baseline (i.e. 100 * (the number of virus copies at Day 7 / number of virus copies at Screening)) Secondary Endpoints:  [SEC 01] Time to virus clearance, defined as days from randomization (Day 1) to negative SARS-CoV-2 RT-PCR test  [SEC 02] Time to recovery in patients who have developed symptoms (recovery is defined as absence of any symptoms mentioned under SEC02B...02E by indicating 0 or 1 on each of the relevant scales, and physiological body temperature as per SEC02A)  [SEC 02A] Time to resolution from fever (oral or tympanic (core body) temperature) ≤ 37.5 °C, axillary, forehead or wrist (surface body) temperature ≤ 37.0 °C for at least 24 hours without antipyretics)  [SEC 02B] Time course of cough burden - cough remission (reduction on a scale of 0-10, compared to Day 1 baseline)  [SEC 02C] Time course of dysgeusia-ageusia (reduction on a scale of 0-10, compared to Day 1 baseline)  [SEC 02D] Time course of anosmia (reduction on a scale of 0-10, compared to Day 1 baseline)  [SEC 02E] Time course of fatigue (reduction on a scale of 0-10, compared to Day 1 baseline)  [SEC 03] Percentage of patients with hospitalization due to progression of COVID-19  [SEC 04] Absenteeism, by self-reporting, expressed in days absent from workplace, due to COVID-19  [SEC 05] Presence of post-COVID symptoms reported by the patient at D28 Safety Endpoint: • [SAF 01] Monitoring Adverse Events, safety laboratory and other safety parameters Number of patients (planned..