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1. Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial

Author

Bharath Kumar Tirupakuzhi Vijayaraghavan, Vivekanand Jha, Dorrilyn Rajbhandari, Sheila Nainan Myatra, Oommen John, Arpita Ghosh, Abhinav Bassi, Sumaiya Arfin, Mallikarjuna Kunigari, Rohina Joshi, Lachlan Donaldson, Naomi Hammond, Balasubramanian Venkatesh, and the HOPE investigators

Subjects
COVID-19, Randomised controlled trial, protocol, hydroxychloroquine, health personnel, Medicine (General), R5-920
Abstract

Abstract Objectives To evaluate the effect of the combination of hydroxychloroquine (HCQ) and standard personal protective equipment (PPE) compared to the use of standard personal protective equipment alone on the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers(HCWs) in India Trial design HOPE is an investigator initiated multi-centre open-label parallel group randomized controlled trial. Participants All HCWs currently working in an environment with direct exposure to patients with confirmed COVID-19 infection are eligible to participate in the trial. The trial aims to be conducted across 20-30 centres (public and private hospitals) in India. HCWs who decline consent, who have a confirmed COVID-19 infection, those who are already on chloroquine/HCQ for any indication, or if pregnant or breast-feeding, or have known QT prolongation or are on medications that when taken with HCQ can prolong the QTc will be excluded. Intervention and comparator The interventions to be compared in this trial are standard practice (use of recommended PPE) and HCQ plus standard practice. In the standard practice arm, HCWs will use recommended PPE as per institutional guidelines and based on their roles. They will be discouraged from taking HCQ to prevent contamination and contacted every week for the duration of the study to ascertain if they have taken any HCQ. Any such use will be reported as a protocol violation. In the intervention arm, HCWs will be administered 800mg of HCQ as a loading dose on the day of randomization (as two 400mg doses 12hrs apart) and subsequently continued on 400mg once a week for 12 weeks. This will be in addition to the use of recommended PPE as per institutional guidelines and based on their roles. HCWs will collect the drug once every week from designated research and pharmacy staff at site. A weekly phone reminder will be provided to participants in this arm to ensure compliance. An ECG will be performed between 4-6 weeks in this arm and if the QTc is prolonged (greater than 450milliseconds), the drug will be stopped. Follow-up will however continue. Participants in both arms will receive a weekly phone call for evaluation of the primary outcome, to monitor protocol compliance and development of any adverse events (in the HCQ group). Main outcomes Participants will be followed on a weekly basis. The primary outcome is the proportion of HCWs developing laboratory confirmed COVID-19 infection within 6 months of randomization. We will also evaluate a number of secondary outcomes, including hospitalization related to suspected/confirmed COVID-19 infection, intensive care unit or high-dependency unit admission due to suspected/confirmed COVID-19 infection, all-cause mortality, need for organ support ( non-invasive or invasive ventilation, vasopressors and renal replacement therapy), ICU and hospital length of stay, readmission, days off work and treatment-related adverse events. Randomisation Randomisation will be conducted through a password-protected, secure website using a central, computer-based randomisation program. Randomisation will be stratified by participating institutions and by the role of HCW – nursing, medical and other. Participants will be randomised 1:1 to either standard practice only or HCQ plus standard practice. Allocation concealment is maintained by central web-based randomisation Blinding (masking) This is an unblinded study: study assigned treatment will be known to the research team and participant. Bias will be mitigated through an objective end point (laboratory confirmed COVID-19 infection). Numbers to be randomised (sample size) A total of 6,950 HCWs will be enrolled (3475 to the intervention) and (3475 to the standard practice group) to detect a 25% relative reduction, or 2.5% absolute reduction, in the infection rate from an estimated baseline infection rate of 10%, with 80% statistical power using a two-sided test at 5% level of significance. Available data from China and Italy indicate that the rate of infection among frontline healthcare workers varies between 4% to 12%. We therefore assumed a baseline infection rate of 10% among HCWs. This sample size allows for a potential loss to follow-up rate of 10% and a potential non-compliance rate of 10% in both the treatment and control arms. Trial Status HOPE protocol version 3.0 dated June 3rd 2020. Recruitment started on 29th June 2020 and currently 56 participants have been enrolled. Planned completion of enrolment is January 31st 2021. Trial registration Clinical Trials Registry of India: CTRI/2020/05/025067 (prospectively registered) Date of registration: 6th May 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expedited dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Published
2020
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2. Hydroxychloroquine plus personal protective equipment versus personal protective equipment alone for the prevention of laboratory-confirmed COVID-19 infections among healthcare workers: a multicentre, parallel-group randomised controlled trial from India.

Author

Tirupakuzhi Vijayaraghavan, BK, Jha, V, Rajbhandari, D, Myatra, SN, Ghosh, A, Bhattacharya, A, Arfin, S, Bassi, A, Donaldson, LH, Hammond, NE, John, O, Joshi, R, Kunigari, M, Amrutha, C, Husaini, SHM, Ghosh, S, Nag, SK, Selvaraj, HK, Kantroo, V, Shah, KD, Venkatesh, B, HOPE Investigators, Tirupakuzhi Vijayaraghavan, BK, Jha, V, Rajbhandari, D, Myatra, SN, Ghosh, A, Bhattacharya, A, Arfin, S, Bassi, A, Donaldson, LH, Hammond, NE, John, O, Joshi, R, Kunigari, M, Amrutha, C, Husaini, SHM, Ghosh, S, Nag, SK, Selvaraj, HK, Kantroo, V, Shah, KD, Venkatesh, B, and HOPE Investigators

Abstract

OBJECTIVES: To determine whether hydroxychloroquine when used with personal protective equipment reduces the proportion of laboratory-confirmed COVID-19 among healthcare workers in comparison to the use of personal protective equipment alone. DESIGN: Multicentre, parallel-group, open-label randomised trial. Enrolment started on 29 June 2020 and stopped on 4 February 2021. Participants randomised in HydrOxychloroquine Prophylaxis Evaluation were followed for 6 months. SETTING: 9 hospitals across India. PARTICIPANTS: Healthcare workers in an environment with exposure to COVID-19 were randomised in a 1:1 ratio to hydroxychloroquine plus use of personal protective equipment or personal protective equipment alone. 886 participants were screened and 416 randomised (213 hydroxychloroquine arm and 203 personal protective equipment). INTERVENTION: Participants in intervention arm received 800 mg of hydroxychloroquine on day of randomisation and then 400 mg once a week for 12 weeks in addition to the use of personal protective equipment. In the control arm, participants continued to use personal protective equipment alone. MAIN OUTCOME: Proportion of laboratory-confirmed COVID-19 in the 6 months after randomisation. RESULTS: Participants were young (mean age 32.1 years, SD 9.1 years) with low-comorbid burden. 47.4% were female. In the 6 months after randomisation (primary analysis population=413), 11 participants assigned to the hydroxychloroquine group and 12 participants assigned to the standard practice group met the primary endpoint (5.2% vs 5.9%; OR 0.85, 95% CI 0.35 to 2.07, p=0.72). There was no heterogeneity of treatment effect in any prespecified subgroup. There were no significant differences in the secondary outcomes. The adverse event rates were 9.9% and 6.9% in the hydroxychloroquine and standard practice arms, respectively. There were no serious adverse events in either group. CONCLUSIONS AND RELEVANCE: Hydroxychloroquine along with personal protective equipment

Published
2022

3. Hydroxychloroquine Plus Standard Personal Protective Equipment Versus Standard Personal Protective Equipment Alone for the Prevention of Laboratory Confirmed Covid-19 Infections Among Healthcare Workers: A Multi-Centre Parallel Group Randomized Controlled Trial from India

Author

Cynthia Amrutha, Subir Ghosh, Amritendu Bhattacharya, Viny Kantroo, Bharath Kumar Tirupakuzhi Vijavaraghavan, Harikrishnan S, Lachlan Donaldson, Kamal D. Shah, Abhinav Bassi, Arpita Ghosh, Rohina Joshi, Santosh Kumar Nag, Syed Haider Mehdi Hussaini, Vivekanand Jha, Oommen John, Sumaiya Arfin, Balasubramanian Venkatesh, Mallikarjuna Kunigari, Naomi E Hammond, Dorrilyn Rajbhandari, Hope Investigators, and Sheila Nainan Myatra

Subjects
History, medicine.medical_specialty, education.field_of_study, Randomization, Polymers and Plastics, business.industry, Population, Hydroxychloroquine, Industrial and Manufacturing Engineering, law.invention, Clinical trial, Regimen, Randomized controlled trial, Informed consent, law, Family medicine, Clinical endpoint, Medicine, Business and International Management, business, education, medicine.drug
Abstract

Background: Healthcare workers (HCWs),particularly from lower-middle income countries (LMIC), are at high risk of acquiring COVID-19. Limited data exist on the effectiveness of hydroxychloroquine as prophylaxis. Our trial evaluated the effectiveness of a 12-week regimen of hydroxychloroquine among HCWs on the risk of laboratory-confirmed COVID-19 in the 6 months after randomization Methods: We conducted a multicentre parallel-group open-label randomized controlled trial in 9 centres across India. HCWs serving in an environment with exposure to COVID-19 were eligible and randomized in a 1:1 ratio to hydroxychloroquine plus standard practice or to standard practice alone (role-appropriate personal protective equipment). In the intervention arm, participants received 2 doses of 400mg hydroxychloroquine at randomization followed by a weekly dose for 12 weeks. The primary outcome was the proportion of laboratory-confirmed COVID-19 in the 6 months after randomization using an intention-to-treat analysis. The trial was registered on Clinical Trials Registry of India(CTRI/2020/05/025067). Findings: From 29th June 2020 to 4th February 2021, 886 participants were screened and 416 were randomized (203-standard practice and 213- hydroxychloroquine plus standard practice). In the 6 months after randomization (primary analysis population=413), 11 participants assigned to the hydroxychloroquine group and 12 participants assigned to the standard practice group met the primary end point[ 5.1% vs 5.9%; OR 0.85, [95% CI 0.35-2.06] p=0.71]. There was no heterogeneity of treatment effect on the primary outcome in any of the pre-specified subgroups. There were no significant differences in any of the secondary outcomes. The adverse event rates were 9.9% and 6.9% in the hydroxychloroquine and standard practice arms respectively. There were no serious adverse events in either group. Interpretation: Hydroxychloroquine along with standard practice was not superior to standard practice alone on the proportion of lab-confirmed COVID-19. However, conclusions are limited by the premature trial cessation. Trial Registration: Clinical Trials Registry of India (CTRI/2020/05/025067). Funding: Wesley Medical Research, Australia Declaration of Interest: OJ reports being a member of the WHO R&D Blueprint Safety Monitoring Team, ACT Acclerator-R&D Digital Health working group and COVID-19 Clinical Research Coalition data sharing working group. Remaining authors have nothing to declare. Ethical Approval: Written informed consent was obtained from all participants. The trial was approved by the Ethics Committee at all participating sites (coordinating centre EC approval number: The George Institute Ethics Committee:08-2020)

Published
2021

4. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease

Author

Irina Chazova, Leopoldo S. Piegas, Alexander Parkhomenko, Jackie Bosch, Patricio Lopez-Jaramillo, Hyejung Jung, Jun Zhu, Gilles R. Dagenais, Eva Lonn, Kamlesh Khunti, Karen Sliwa, Antonio L. Dans, Hope Investigators, Salim Yusuf, Petr Jansky, Basil S. Lewis, Matyas Keltai, John Varigos, Gregorio Sanchez-Vallejo, Ron J.G. Peters, Lisheng Liu, Denis Xavier, Janice Pogue, Robert S. McKelvie, Alvaro Avezum, Claes Held, William D. Toff, Katalin Keltai, Christopher M. Reid, Lawrence A. Leiter, Rafael Diaz, Prem Pais, Khalid Yusoff, Peggy Gao, ACS - Amsterdam Cardiovascular Sciences, APH - Amsterdam Public Health, and Cardiology

Subjects
Male, medicine.medical_specialty, Population, Hypercholesterolemia, 030204 cardiovascular system & hematology, Placebo, law.invention, Medication Adherence, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Risk Factors, Internal medicine, medicine, Humans, Rosuvastatin, 030212 general & internal medicine, Myocardial infarction, Rosuvastatin Calcium, education, Aged, education.field_of_study, Cholesterol lowering, business.industry, Cholesterol, Intermediate risk, General Medicine, Cholesterol, LDL, Middle Aged, medicine.disease, Cardiovascular disease, chemistry, Cardiovascular Diseases, Heart failure, Physical therapy, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitors, business, medicine.drug
Abstract

11 p., BACKGROUND Previous trials have shown that the use of statins to lower cholesterol reduces the risk of cardiovascular events among persons without cardiovascular disease. Those trials have involved persons with elevated lipid levels or inflammatory markers and involved mainly white persons. It is unclear whether the benefits of statins can be extended to an intermediate-risk, ethnically diverse population without cardiovascular disease. METHODS In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants in 21 countries who did not have cardiovascular disease and were at intermediate risk to receive rosuvastatin at a dose of 10 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included revascularization, heart failure, and resuscitated cardiac arrest. The median follow-up was 5.6 years. RESULTS The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group. The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002). The results for the second coprimary outcome were consistent with the results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P

Published
2016

5. Long-term Effects of Statins, Blood Pressure-Lowering, and Both on Erectile Function in Persons at Intermediate Risk for Cardiovascular Disease : A Substudy of the Heart Outcomes Prevention Evaluation-3 (HOPE-3) Randomized Controlled Trial

Author

William D. Toff, Christopher M. Reid, Anthony Dans, Jackie Bosch, Patricio Lopez, Michael Böhm, Jun Zhu, Leopoldo S. Piegas, Eva Lonn, Matyas Keltai, Hope Investigators, Salim Yusuf, Jae-Hyung Kim, Kamlesh Khunti, Philip Joseph, and Balakumar Swaminathan

Subjects
Male, medicine.medical_specialty, Libido, 030232 urology & nephrology, Tetrazoles, Blood Pressure, 030204 cardiovascular system & hematology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Hydrochlorothiazide, Randomized controlled trial, Double-Blind Method, Risk for Cardiovascular Diseas, law, Risk Factors, Internal medicine, Medicine, Humans, Rosuvastatin, HOPE-3, Risk factor, Rosuvastatin Calcium, Blood Pressure-Lowering, Erectile Function, Antihypertensive Agents, business.industry, Penile Erection, Biphenyl Compounds, Cholesterol, LDL, Middle Aged, medicine.disease, Candesartan, Blood pressure, Erectile dysfunction, Cardiovascular Diseases, Benzimidazoles, Drug Therapy, Combination, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Cardiology and Cardiovascular Medicine, business, Sexuality, medicine.drug
Abstract

7 p., Background: It is unclear whether modifying cholesterol, blood pressure, or both affect erectile dysfunction. Also, there are concerns that erectile dysfunction is worsened by common medications used to treat these risk factors. In this study, we evaluated the effect of: (1) cholesterol-lowering with a statin; (2) pharmacologic blood pressure reduction; and (3) their combination, on erectile function. Methods: A priori, this was a secondary analysis of the Heart Outcomes Prevention Evaluation-3 (HOPE-3) randomized controlled trial. Men were 55 years of age or older with at least 1 cardiovascular risk factor. Erectile function was measured using the erectile function domain of the International Index of Erectile Function (IIEF-EF) score. Men with incomplete scores, or who did not engage in sexual activity, were excluded. Using a 2 × 2 factorial design, participants were randomized to rosuvastatin (10 mg/d) or placebo, and to candesartan with hydrochlorothiazide (HCTZ; 16 mg/12.5 mg/d; Cand+HCTZ) or placebo. Primary outcome was change in IIEF-EF from baseline to end of study follow-up. Results: Two thousand one hundred fifty-three men were included; mean age was 61.5 years, and mean follow-up was 5.8 years. Mean IIEF-EF score at baseline was 23.0 (SD 5.6). Least square mean change in the IIEF-EF score did not differ with rosuvastatin compared with placebo (−1.4; standard error [SE], 0.3 vs −1.5; SE, 0.3; P = 0.74), Cand+HCTZ compared with placebo (−1.6; SE, 0.3 vs −1.3; SE, 0.3; P = 0.10), or combination therapy compared with double placebo (P = 0.35). Conclusions: Cholesterol-lowering using a statin, and blood pressure-lowering using Cand+HCTZ, either alone or in combination, do not improve or adversely affect erectile function.

Published
2018

6. Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial.

Author

Tirupakuzhi Vijayaraghavan, Bharath Kumar, Jha, Vivekanand, Rajbhandari, Dorrilyn, Myatra, Sheila Nainan, John, Oommen, Ghosh, Arpita, Bassi, Abhinav, Arfin, Sumaiya, Kunigari, Mallikarjuna, Joshi, Rohina, Donaldson, Lachlan, Hammond, Naomi, Venkatesh, Balasubramanian, the HOPE investigators, Vijayaraghavan, Bharath Kumar Tirupakuzhi, Nag, Santosh Kumar, Husaini, Syed Haider Mehdi, Kantro, Viny, Singh, Ashita, and Mathew, Arpit

Subjects
PERSONAL protective equipment, HEALTH care reminder systems, RANDOMIZED controlled trials, HYDROXYCHLOROQUINE, CLINICAL trial registries, INFECTION prevention, COMPUTER password security, SMART cards
Abstract

Objectives: To evaluate the effect of the combination of hydroxychloroquine (HCQ) and standard personal protective equipment (PPE) compared to the use of standard personal protective equipment alone on the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers(HCWs) in India TRIAL DESIGN: HOPE is an investigator initiated multi-centre open-label parallel group randomized controlled trial.Participants: All HCWs currently working in an environment with direct exposure to patients with confirmed COVID-19 infection are eligible to participate in the trial. The trial aims to be conducted across 20-30 centres (public and private hospitals) in India. HCWs who decline consent, who have a confirmed COVID-19 infection, those who are already on chloroquine/HCQ for any indication, or if pregnant or breast-feeding, or have known QT prolongation or are on medications that when taken with HCQ can prolong the QTc will be excluded.Intervention and Comparator: The interventions to be compared in this trial are standard practice (use of recommended PPE) and HCQ plus standard practice. In the standard practice arm, HCWs will use recommended PPE as per institutional guidelines and based on their roles. They will be discouraged from taking HCQ to prevent contamination and contacted every week for the duration of the study to ascertain if they have taken any HCQ. Any such use will be reported as a protocol violation. In the intervention arm, HCWs will be administered 800mg of HCQ as a loading dose on the day of randomization (as two 400mg doses 12hrs apart) and subsequently continued on 400mg once a week for 12 weeks. This will be in addition to the use of recommended PPE as per institutional guidelines and based on their roles. HCWs will collect the drug once every week from designated research and pharmacy staff at site. A weekly phone reminder will be provided to participants in this arm to ensure compliance. An ECG will be performed between 4-6 weeks in this arm and if the QTc is prolonged (greater than 450milliseconds), the drug will be stopped. Follow-up will however continue. Participants in both arms will receive a weekly phone call for evaluation of the primary outcome, to monitor protocol compliance and development of any adverse events (in the HCQ group).Main Outcomes: Participants will be followed on a weekly basis. The primary outcome is the proportion of HCWs developing laboratory confirmed COVID-19 infection within 6 months of randomization. We will also evaluate a number of secondary outcomes, including hospitalization related to suspected/confirmed COVID-19 infection, intensive care unit or high-dependency unit admission due to suspected/confirmed COVID-19 infection, all-cause mortality, need for organ support ( non-invasive or invasive ventilation, vasopressors and renal replacement therapy), ICU and hospital length of stay, readmission, days off work and treatment-related adverse events.Randomisation: Randomisation will be conducted through a password-protected, secure website using a central, computer-based randomisation program. Randomisation will be stratified by participating institutions and by the role of HCW - nursing, medical and other. Participants will be randomised 1:1 to either standard practice only or HCQ plus standard practice. Allocation concealment is maintained by central web-based randomisation BLINDING (MASKING): This is an unblinded study: study assigned treatment will be known to the research team and participant. Bias will be mitigated through an objective end point (laboratory confirmed COVID-19 infection).Numbers To Be Randomised (sample Size): A total of 6,950 HCWs will be enrolled (3475 to the intervention) and (3475 to the standard practice group) to detect a 25% relative reduction, or 2.5% absolute reduction, in the infection rate from an estimated baseline infection rate of 10%, with 80% statistical power using a two-sided test at 5% level of significance. Available data from China and Italy indicate that the rate of infection among frontline healthcare workers varies between 4% to 12%. We therefore assumed a baseline infection rate of 10% among HCWs. This sample size allows for a potential loss to follow-up rate of 10% and a potential non-compliance rate of 10% in both the treatment and control arms.Trial Status: HOPE protocol version 3.0 dated June 3rd 2020. Recruitment started on 29th June 2020 and currently 56 participants have been enrolled. Planned completion of enrolment is January 31st 2021.Trial Registration: Clinical Trials Registry of India: CTRI/2020/05/025067 (prospectively registered) Date of registration: 6th May 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expedited dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). [ABSTRACT FROM AUTHOR]

Published
2020
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