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Clinical Trial Protocol Iranian Registry of Clinical Trials

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Clinical Trial Protocol Iranian Registry of Clinical Trials Clinical Trial Protocol Iranian Registry of Clinical Trials 29 Sep 2021 Randomzied trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care- Iranian SOLIDARITY multicentre trial Protocol summary Main outcome variables Main Outcome: All-cause mortality Major Secondary Study aim Outcomes: -Duration of hospitalization -Time to Main Aim: To evaluate the safety and efficacy of ventilation (ICU Care) medications in treating COVID-19 Specific Aims: -To evaluate the safety and efficacy of Remdesivir in treating General information COVID-19 -To evaluate the safety and efficacy of Chloroquine/Hydroxychloroquine in treating COVID-19 - Reason for update To evaluate the safety and efficacy of Lopinovir/Retinovir Acronym in treating COVID-19 -To evaluate the safety and efficacy IRCT registration information of Lopinovir/Retinovir along with Interferon in treating IRCT registration number: IRCT20200405046953N1 COVID-19 -To compare the efficacy of medications in Registration date: 2020-04-06, 1399/01/18 treating COVID-19 Registration timing: prospective Design Five-Arm, Multi-center, randomized controlled trial Last update: 2020-04-06, 1399/01/18 Settings and conduct Update count: 0 This trial will be performed in 30 hospitals throughout Registration date Iran. Clinicians will randomize patients using the study 2020-04-06, 1399/01/18 website and provide the appropriate treatment per protocol. Registrant information Participants/Inclusion and exclusion criteria Name Inclusion Criteria: -Adults (age ≥18) -Hospitalised with Hossein Poustchi definite COVID-19 diagnosis, not already receiving any of Name of organization / entity the study medications -No known allergy or Country contraindications to any of the study medications - Iran (Islamic Republic of) Patients admitted to collaborating hospitals, without Phone anticipated transfer within 72 hours Exclusion Criteria: - +98 21 8241 5204 Anyone having a significant contraindication to any one Email address of the study drugs -Serious chronic liver or heart disease [email protected] -Pregnancy Intervention groups Recruitment status • Local standard of care alone OR local standard of care Recruitment complete plus one of: • Remdesivir (daily infusion for 10 days) • Funding source Chloroquine or Hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days) [NB Some Expected recruitment start date collaborating hospitals will study chloroquine, others 2020-04-08, 1399/01/20 hydroxychloroquine] • Lopinavir with Ritonavir (orally Expected recruitment end date twice daily for 14 days) • Lopinavir with Ritonavir (ditto) 2020-06-09, 1399/03/20 plus Interferon (daily injection for 6 days). Actual recruitment start date 1 empty Other design features Actual recruitment end date empty Secondary Ids Trial completion date empty empty Scientific title Ethics committees Randomzied trial of additional treatments for COVID-19 in hospitalized patients who are all receiving the local standard of care- Iranian SOLIDARITY multicentre trial 1 Public title Ethics committee Comparison of therapies for COVID-19 Name of ethics committee Purpose National Institute for Medical Research Development Treatment (NIMAD) Inclusion/Exclusion criteria Street address Inclusion criteria: No. 21, Be'sat Alley, East Fatemi St. Tehran, Iran Adults (age ≥18) Hospitalised with definite COVID-19 City diagnosis, not already receiving any of the study Tehran medications No known allergy or contraindications to any Province of the study medications Patients admitted to Tehran collaborating hospitals, without anticipated transfer Postal code within 72 hours 1419693111 Exclusion criteria: Approval date Anyone having a significant contraindication to any one 2020-04-02, 1399/01/14 of the study drugs Serious chronic liver or heat disease Ethics committee reference number Pregnancy IR.NREC.1399.001 Age From 18 years old Health conditions studied Gender Both 1 Phase 3 Description of health condition studied Groups that have been masked COVID-19 No information ICD-10 code Sample size U07.1 Target sample size: 3000 ICD-10 code description Randomization (investigator's opinion) COVID-19 Randomized Randomization description Primary outcomes Given that this study is part of the SOLIDARITY Trial by the World Health Organization, the randomization method is only known by the Principal Investigators. 1 Patients will be randomized through the study website Description equally between all the locally available treatment Primary Outcome: All-cause mortality regimens (5 possibilities if all study drugs are locally Timepoint available, fewer if not) • Local standard of care alone, OR Any time death or discharge of patients occurs local standard of care plus one of • Remdesivir (daily Method of measurement infusion for 10 days) • Chloroquine or Death certificate signed by hospital clinicians or Hydroxychloroquine (two oral loading doses, then orally discharge documents twice daily for 10 days) [NB Some collaborating hospitals will study chloroquine, others hydroxychloroquine] • Lopinavir with Ritonavir (orally twice daily for 14 days) • Secondary outcomes Lopinavir with Ritonavir (ditto) plus Interferon (daily injection for 6 days). 1 Blinding (investigator's opinion) Not blinded Description Blinding description Duration of Hospital Stay Placebo Timepoint Not used Any time during the study Assignment Method of measurement Parallel Based on Medical Charts 2 2 City Tehran Description Province Time to ventilation (ICU Care) Tehran Timepoint Postal code Any time during the study 1111111111 Method of measurement Email Based on Medical Chart [email protected] Intervention groups 2 1 Recruitment center Name of recruitment center Description Imam Khomeini Hospital Complex Intervention group: local standard of care plus Full name of responsible person Remdesivir (daily infusion for 10 days) Mohammad Reza Salehi Category Street address Treatment - Drugs Keshavarz Blvd. Dr. Gharib St. City 2 Tehran Province Description Tehran Intervention group: local standard of care plus Postal code Chloroquine or Hydroxychloroquine (two oral loading 1419733141 doses, then orally twice daily for 10 days) Email Category [email protected] Treatment - Drugs 3 3 Description Recruitment center Intervention group: local standard of care plus Lopinavir Name of recruitment center with Ritonavir (orally twice daily for 14 days) Loghman Hakim Hospital Category Full name of responsible person Treatment - Drugs Ilad Alavi Darazam Street address Karegare Jonoobi Ave, Lashgar , Makhsoos St. 4 City Description Tehran Intervention group: local standard of care plus Lopinavir Province with Ritonavir (ditto) plus Interferon (daily injection for 6 Tehran days). Postal code Category 1333635445 Treatment - Drugs Email [email protected] 5 Description 4 Control group: local standard of care Recruitment center Category Name of recruitment center Treatment - Drugs FIroozgar Hospital Full name of responsible person Recruitment centers Mitra Ranjbar Street address Valiasr Sq. Karimkhan St. Beh Afarin St. 1 City Recruitment center Tehran Name of recruitment center Province Baharloo Hospital Tehran Full name of responsible person Postal code Hadiseh Hosami 1593747811 Street address Email Behdari St. [email protected] 3 5 City Mashhad Recruitment center Province Name of recruitment center Razavi Khorasan Masih Danesvari Hospital Postal code Full name of responsible person 9351899983 Payam Tabarsi Email Street address [email protected] Shahid Bahonar St. Darabad St. City Tehran 9 Province Recruitment center Tehran Name of recruitment center Postal code Ali Asghar Hospital 1956944413 Full name of responsible person Email Mohsen Moghadami [email protected] Street address Meshkin Fam St. 6 City Recruitment center Shiraz Name of recruitment center Province Imam Ali Hospital Fars Full name of responsible person Postal code Alireza Soleimani 7143918796 Street address Email Resalat Intersection [email protected] City Karaj 10 Province Recruitment center Alborz Name of recruitment center Postal code Chamran Hospital 3154686695 Full name of responsible person Email Mohsen Moghadami [email protected] Street address Shahid Chamran Blvd. 7 City Recruitment center Shiraz Name of recruitment center Province Imam Reza Hospital Fars Full name of responsible person Postal code Mahnaz Amini 7194815644 Street address Email Imam Reza Square [email protected] City Mashhad 11 Province Razavi Khorasan Recruitment center Postal code Name of recruitment center 9137913316 Shahid Beheshti Email Full name of responsible person [email protected] Ahmad Hormati Street address Shahid Beheshti Sq. Azadegan Blvd. 8 City Recruitment center Qom Name of recruitment center Province Shariati Hospital Ghoum Full name of responsible person Postal code Saeid Hafizi Lotfabadi 1111111111 Street address Email Vakil Abad Ave. Imam Reza Alley [email protected] 4 12 City Isfahan Recruitment center Province Name of recruitment center Isfehan Kamkar Hospital Postal code Full name of responsible person 8174675731 Mohammad Reza Ghadir Email Street address [email protected] Dey 19th St. City Qom 16 Province Recruitment center Ghoum Name of recruitment center Postal code Khorshid Hospital 1111111111 Full name of responsible person Email Kiana Shirani [email protected] Street address Ostandari St. 13 City Recruitment center Isfahan Name of recruitment center Province Shahid Sadoughi Hospital Isfehan Full name of responsible person Postal code Alireza Musavi 1111111111
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