IRCCS Sacro Cuore Don Calabria Hospital is an accredited Italian provider in the Veneto region that accommodates about 30,000 patients per year, includes 968 beds and employs approximately 1,712. The regional provider has come together with Mario Negri Institute for Pharmacological Research, a nonprofit research institute dedicated to clinical and biomedical research, to conduct the ‘COVER trial’, a 102 patient, prospective, multi-center, randomized, double-blind trial to assess efficacy and safety of Ivermectin for the treatment of initial infection with SARS-CoV-2 infection. Led by infectious and tropical disease expert Dr. Zeno Bisoffi, the study nears launch and will be conducted through August with final reports planned for October 2020. The study will span regions of Italy and Spain.
The Sponsor Collaborative
The Mario Negri Institute for Pharmacological Research was originally funded by Milan philanthropist Mario Negri and founded by Silvio Garattini, a well-known Italian physician, chemist and researcher. The IRCCS Sacro Cuore Don Calabria Hospital commenced operations as a hospital in 1944 and was classified by 1970 as a “Local General Hospital.” Accredited in the Veneto region, it includes an infectious and tropical disease institute as well as acute care hospital, care for the elderly and totals 968 beds.
This Phase 2 clinical trial is known as the COVER trial or “COVidIVERmectin: Ivermectin for Treatment of COVID-19” targets 102 patients. The prospective, multi-center, randomized, double-blind clinical trial has been designed so that Italian investigators can evaluate the efficacy and safety of Ivermectin for the treatment of initial infection of SARS-CoV-2, the virus behind the COVID-19 pandemic.
The sponsors have set up three study arms including (A) placebo and (B) Ivermectin 600 ug/kg daily for 5 consecutive days ( I_600 ) + placebo and (C) Ivermectin 1200 ug/kg daily at empty stomach with water for 5 consecutive days (I_1200). Patients will be randomized at emergency room of hospitals in addition to outpatient ambulatory care and at home, based on routine procedures of recruiting centers established by the sponsors.
The sponsors disclosed that for arms A and B the total number of placebo tablets involved will actually be calculated by a study dedicated pharmacist factoring in the number of tablets that should be taken in case the patient with the same weight is assigned to arm C.
Primary outcomes include 1) number of serious drug adverse reactions within 14 day period, and 2) viral load assessed after day 7 (measured by quantitative, digital droplet PCR). The study sponsors include six secondary outcome measures.
Patients must be 18 or older, positively confirmed with SARS-CoV-2 (via nasopharyngeal swabs); consent to participation and the processing of personal data; a COVID-19 severity score of greater than 3 and ability to take oral drugs. On the other hand, any patient that is pregnant or lactating, suffers from known CNS disease, doesn’t provide informed consent, under dialysis, has any severe medical condition within prognosis of greater than 6 months, under either warfarin or antiviral or chloroquine or hydroxychloroquine treatment would be excluded from participation in this study.
Multi-Center Study Spanning Italy and Spain
The collaborative sponsors have opened this study up to multiple sites in Italy and in Spain.
In Italy, the sites include the following:
· IRCCS Sacro Cuore Don Calabria Hospital (Negrar Verona)
· Policlinico S. Orsola (Bologna)
· Ospedale Luigi Sacco (Milan)
· Ospedale di Rovereto (Rovereto)
· Ospedale Amedeo di Savoia (Turin)
While in Spain the following sites are involved:
· Hospital Clinic/IS Global (Barcelona)
· Hospital La Paz-Carlos III (Madrid)
Dr. Bisoffi, associated with the University of Verona, obtained his PhD in Medical Sciences at the University of Antwerp. Since 2017 he has been an Associate Professor of Infectious and Tropical Diseases, under agreement with Sacro-Cuore Don Calabria Hospital, Negrar Verona—the study’s primary sponsor. He is a doctor at the hospital’s Center for Tropical Diseases and his main research areas of interest include malaria and neglected tropical diseases in particular strongyloidiasis and schistosomiasis, and the optimal clinical-diagnostic approach to tropical and parasitic diseases.
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