RCT protocols

Title NCT Journal Authors Link
The COVIRL-001 Trial: A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: A structured summary of a study protocol for a randomised controlled trial. EudraCT: No. 2020-001265-36 Trials Feeney E Link
ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial. EudraCT: 2020-001331-26 Trials McEniery, C Link
Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial. NCT04410562 EudraCT: 2020-001587-29 Trials Gonzalez, R Link
Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial. NCT04361435 Trials Kawaguchi, Atsushi and Bernier, Gabrielle and Lacroix, Jacques and El Salti, Saly and Cheng, Matthew P and Lee, Todd C and Khwaja, Kosar and Jouvet, Philippe Link
The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial. ChiCTR2000029972 Trials Nasb, Mohammad and Sayed Shah, Zulfiqar Ali and Huang, Liangjiang and Li, Qian and Chen, Hong Link
Impact of vitamins A, B, C, D, and E supplementation on improvement and mortality rate in ICU patients with coronavirus-19: a structured summary of a study protocol for a randomized controlled trial. IRCT20200319046819N1 Trials Beigmohammadi, Mohammad Taghi; Bitarafan, Sama; Hoseindokht, Azin; Abdollahi, Alireza; Amoozadeh, Laya; Mahmoodi Ali Abadi, Maedeh; Foroumandi, Morteza; Link
Test and treat COVID 65 plus - Hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of older patients with COVID19: A structured summary of a study protocol for a randomised controlled trial. NCT04351516 EudraCT: 2020-001482-37 Trials Göpel, Siri and Bethge, Wolfgang and Martus, Peter and Kreth, Florian and Iftner, Thomas and Joos, Stefanie and Döbele, Stefanie and Mordmüller, Benjamin and Kremsner, Peter and Ettrich, Thomas and Seufferlein, Thomas and Bitzer, Michael and Malek, Nisar Link
Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial. NCT04264533 BMJ open Liu, Fang and Zhu, Yuan and Zhang, Jing and Li, Yiming and Peng, Zhiyong Link
Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)-protocol of randomised controlled trial AZIQUINE-ICU. NCT04339816 EudraCT: 2020-001456-18 Trials Duška, František and Waldauf, Petr and Halačová, Milada and Zvoníček, Václav and Bala, Jakub and Balík, Martin and Beneš, Jan and Klementová, Olga and Kozáková, Irena and Kubricht, Viktor and Le Roy, Anne and Vymazal, Tomáš and Řehořová, Veronika and Černý, Vladimír and Czech Anaesthesia Clinical Trials and Audit Network, [Collective Name] Link
Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial. NCT04390464 EudraCT: 2020-001354-22 Trials Kulkarni, Spoorthy and Fisk, Marie and Kostapanos, Michalis and Banham-Hall, Edward and Bond, Simon and Hernan-Sancho, Elena and Norton, Sam and Cheriyan, Joseph and Cope, Andrew and Galloway, James and Hall, Frances and Jayne, David and Wilkinson, Ian B Link
Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study. ChiCTR2000029741 Trials Liu, Xi and Chen, Huili and Shang, Yuqi and Zhu, Hongqiong and Chen, Gongqi and Chen, Yuanli and Liu, Shaoxuan and Zhou, Yaoyong and Huang, Mingxing and Hong, Zhongsi and Xia, Jinyu Link
Outpatient treatment of COVID-19 with steroids in the phase of mild pneumonia without the need for admission as an opportunity to modify the course of the disease: A structured summary of a randomised controlled trial. EudraCT: 2020-001622-64 Trials Saiz-Rodríguez, Miriam and Peña, Teresa and Lázaro, Lourdes and González, Ángel and Martínez, Andrés and Cordero, José A and Vicente, Juan T and Richard, Fernando and Coma, María Jesús and de Frutos, Martín and Labrador, Jorge and Pueyo, Ana Link
Protocol for a multicentre randomized controlled trial of normobaric versus hyperbaric oxygen therapy for hypoxemic COVID-19 patients * Boet, S. Link
The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial. Australian New Zealand Clinical Trials Registry(ACTRN12620000445976 ) Trials Denholm, Justin T and Davis, Joshua and Paterson, David and Roberts, Jason and Morpeth, Susan and Snelling, Thomas and Zentner, Dominica and Rees, Megan and O'Sullivan, Matthew and Price, David and Bowen, Asha and Tong, Steven Y C and ASCOT Investigator Group, [Collective Name] Link
Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada. ISRCTN14326006 Trials Wright, Julie K and Tan, Darrell H S and Walmsley, Sharon L and Hulme, Jennifer and O'Connor, Erin and Snider, Carolyn and Cheng, Ivy and Chan, Adrienne K and Borgundvaag, Bjug and McLeod, Shelley and Gollob, Michael H and Clarke, Rosemarie J and Dresser, Linda and Haji, Fatima and Mazzulli, Tony and Mubareka, Samira and Jüni, Peter and Lee, Dominic and Tomlinson, George and Kain, Kevin C and Landes, Megan Link
A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial. NCT04369469 Trials Smith, Keisha and Pace, Amy and Ortiz, Stephan and Kazani, Shamsah and Rottinghaus, Scott Link
Hydroxychloroquine for Early Treatment of Adults with Mild Covid-19: A Randomized-Controlled Trial. * Clinical infectious diseases : an official publication of the I Mitjà, Oriol and Corbacho-Monné, Marc and Ubals, Maria and Tebe, Cristian and Peñafiel, Judith and Tobias, Aurelio and Ballana, Ester and Alemany, Andrea and Riera-Martí, Núria and Pérez, Carla A and Suñer, Clara and Laporte, Pep and Admella, Pol and Mitjà, Jordi and Clua, Mireia and Bertran, Laia and Sarquella, Maria and Gavilán, Sergi and Ara, Jordi and Argimon, Josep M and Casabona, Jordi and Cuatrecasas, Gabriel and Cañadas, Paz and Elizalde-Torrent, Aleix and Fabregat, Robert and Farré, Magí and Forcada, Anna and Flores-Mateo, Gemma and Muntada, Esteve and Nadal, Núria and Narejos, Silvia and Gil-Ortega, Aroa N and Prat, Nuria and Puig, Jordi and Quiñones, Carles and Reyes-Ureña, Juliana and Ramírez-Viaplana, Ferran and Ruiz, Lidia and Riveira-Muñoz, Eva and Sierra, Alba and Velasco, César and Vivanco-Hidalgo, Rosa Maria and Sentís, Alexis and G-Beiras, Camila and Clotet, Bonaventura and Vall-Mayans, Martí and BCN PEP-CoV-2 RESEARCH GROUP, [Collective Name] Link
Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19: A Randomized Trial. NCT04308668 Annals of internal medicine Skipper, Caleb P and Pastick, Katelyn A and Engen, Nicole W and Bangdiwala, Ananta S and Abassi, Mahsa and Lofgren, Sarah M and Williams, Darlisha A and Okafor, Elizabeth C and Pullen, Matthew F and Nicol, Melanie R and Nascene, Alanna A and Hullsiek, Kathy H and Cheng, Matthew P and Luke, Darlette and Lother, Sylvain A and MacKenzie, Lauren J and Drobot, Glen and Kelly, Lauren E and Schwartz, Ilan S and Zarychanski, Ryan and McDonald, Emily G and Lee, Todd C and Rajasingham, Radha and Boulware, David R Link
Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19. NCT04252274 Open forum infectious diseases Chen, Jun and Xia, Lu and Liu, Li and Xu, Qingnian and Ling, Yun and Huang, Dan and Huang, Wei and Song, Shuli and Xu, Shuibao and Shen, Yingzhong and Lu, Hongzhou Link
Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol. NCT03640455 Frontiers in medicine Azabou, Eric and Bao, Guillaume and Heming, Nicholas and Bounab, Rania and Moine, Pierre and Chevallier, Sylvain and Chevret, Sylvie and Resche-Rigon, Matthieu and Siami, Shidaps and Sharshar, Tarek and Lofaso, Frederic and Annane, Djillali Link
Hydroxychloroquine in Outpatient Adults With COVID-19 NCT04333654 Link
Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial. NCT04331834 Trials Grau-Pujol B; Camprubí D; Marti-Soler H; Fernández-Pardos M; Guinovart C; Muñoz J; Link
RECOVERY- Respiratory Support: Respiratory Strategies for patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow Nasal Oxygen, and standard care: A structured summary of a study protocol for a randomised controlled trial. ISRCTN16912075 Trials Perkins GD; Couper K; Connolly B; Baillie JK; Bradley JM; Dark P; De Soyza A; Gorman E; Gray A; Hamilton L; Hart N; Ji C; Lall R; McGowan N; Regan S; Simonds AK; Skilton E; Stallard N; Stimpson E; Yeung J; McAuley DF; Link
Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial. NCT 04257656 Trials Wang Y Link
Efficacy of Liu-zi-jue in Patients with 2019 Novel Coronavirus Pneumonia (COVID-19): structured summary of a study protocol for a randomized controlled trial. ChiCTR2000032367 Trials Zhang S Link
Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with Suspected or Confirmed COVID-19 (HAHPS): Protocol for a Pragmatic, Open Label, Active Comparator Trial. NCT04329832 Annals of the American Thoracic Society Brown S Link
An online solution focused brief therapy for adolescent anxiety during the novel coronavirus disease (COVID-19) pandemic: a structured summary of a study protocol for a randomised controlled trial. ChiCTR2000030989 Trials Chen S Link
Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial. NCT04308668 Canadian journal of anaesthesia Lother S Link
Effectiveness of glucocorticoid therapy in patients with severe coronavirus disease 2019: protocol of a randomized controlled trial. ChiCTR2000029386 Chinese medical journal Qin Y Link
Hydroxychloroquine alone or in combination with azithromycin to prevent major clinical events in hospitalised patients with coronavirus infection (COVID-19): rationale and design of a randomised, controlled clinical trial NCT04322123 medrxiv Cavalcanti AB Link
A Proposed Randomized, Double Blind, Placebo Controlled Study Evaluating Doxycycline for the Prevention of COVID-19 Infection and Disease In Healthcare Workers with Ongoing High Risk Exposure to COVID-19 * medrxiv Yates PA Link
Plasma from donors recovered from the new Coronavirus 2019 as therapy for critical patients with COVID-19 (COVID-19 plasma study): a multicentre study protocol. NCT04321421 Internal and emergency medicine Perotti C Link
An open label cluster randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19 (ARCHAIC) - Protocol publication * European journal of clinical investigation Weehuizen JM Link
Rationale and Design of ORCHID: A Randomized Placebo-Controlled Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19. NCT04332991 Annals of the American Thoracic Society Casey J Link
A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial. EudraCT: No. 2020-001408-41 Trials Rilinger J Link
Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial. Eudra CT: No. 2020-001704-42 Trials Cuadrado-Lavan A Link
Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial.  NCT04328961 Trials Barnabas RV Link
A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial. EudraCT: No. 2020-001530-35 Trials Garci­a I Link
Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial. NCT03042143 Trials Gorman E Link
Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial. NCT04343768 Trials Irvani S Link
A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial. German CT Register :DRKS00021582 Trials Vandormael A Link
Umbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: a structured summary of a study protocol for a pilot randomised controlled trial. ACTRN12620000478910  Trials Malhotra A Link
Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial. IRCT20120826010664N6 Trials Pirjani R Link
Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial. NCT04330638 Trials Maes Link
Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial. NCT04326920 Trials Bosteels B Link
Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial. NCT04316377 Trials Lyngbakken M Link
The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial. NCT04333589 Trials Li J Link
Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial. NCT04360980 Trials Dalili N Link
Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials. NCT04328441 Trials Ten Doesschate T Link
Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease. NCT04335786 American heart journal Gommans DH Link
Protocol for a randomized controlled trial testing inhaled nitric oxide therapy in spontaneously breathing patients with COVID-19. * medRxiv Berra, L. Link
Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial. NCT04359810 Trials Eckhardt C Link
Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial. NCT04334265 Trials Zhang C Link
A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol. ISRCTN21363594 Trials Faqihi F Link
The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial. EudraCT: No. 2020-001474-29 Trials Chaccour C Link
Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial.  NCT04341493 Trials Calderon J Link
Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial. NCT04322396 Trials Sivapalan, P Link
An internet-based intervention to face stress during social isolation with guided relaxation and meditation: protocol for a randomized controlled study. PRR1-10.2196/19236 JMIR research protocols Pizzoli, Link
Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II). NCT04336254 Trials Ye, Q Link
A description of Covid-19 modifications to the TEAMS study protocol for remotely delivering teleassessment/teletraining of complementary alternative medicine among people with multiple sclerosis: protocol for a randomized controlled effectiveness trial. NCT03117881 JMIR research protocols Lai, B Link
Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial. NCT04355364 Trials Desilles, J P Link
Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial. IRCT20120225009124N4 Trials Abdolahi, N Link
AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial. EudraCT: No. 2020-001860-27 Trials Griffiths, G Link
Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial. NCT04348513 Trials Pantos, C Link
A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial". NCT04368156 Trials Tornero, C Link
Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol. EudraCT: No. 2020-001972-13 Trials Marietta, M Link
Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial. Brazilian CT Registry RBR-6m69fc Trials Gonzalez-Gerez, J J Link
COVID-19-associated ARDS treated with DEXamethasone (CoDEX): Study design and rationale for a randomized trial. NCT04327401 medRxiv Tomazini, B. M. Link
Protocol of a randomized controlled trial testing inhaled Nitric Oxide in mechanically ventilated patients with severe acute respiratory syndrome in COVID-19 (SARS-CoV-2). NCT04306393 medRxiv Lei, C. Link

Recommendations on Core Outcome Sets for clinical trials or clinical research are being developed by the COMET Initiative.