7. Characteristics of studies awaiting classification.
Study | Sponsor/developer | Design | Place of residence (World Bank 2021) | Population/disease severity | Setting | Drug | Route of administration | Number of participants | Status |
EUCTR2020‐001333‐13‐FR | Groupe Hospitalier Paris Saint‐Joseph | RCT | High‐income country (France) |
Included: patient diagnosed COVID positive by RT‐PCR and/or scanner (patients admitted with already mechanical ventilation and sedation, or with acute respiratory failure evolving very quickly) | Inpatient | Dexamethasone | IV | 122 | Prematurely ended |
EUCTR2020‐001307‐16‐ES |
Fundación para la Investigación Biomédica Hospital Ramón y Cajal | RCT | High‐income country (Spain) |
ARDS | Inpatient | Methylprednisolone | IV | 104 | Prematurely ended |
EUCTR2020‐001553‐48‐FR | Hospices Civils de Lyon | RCT | High‐income country (France) |
Peripheral saturation by pulse oximeter SpO2 ≤ 94% in ambient air measured twice at 5‐ to 15‐min intervals, or PaO2/FiO2 < 300 mmHg | Inpatient | Prednisone | Oral | 304 | Prematurely ended |
IRCT20081027001411N3 | Teheran University of Medical Sciences | RCT | Middle‐income country (Iran) |
Blood oxygen saturation < 93%; with ARDS | Inpatient | Prednisolone | Not stated | 60 | Completed |
IRCT20120215009014N354 | Hamedan University of Medical Sciences | RCT | Middle‐income country (Iran) |
Hospitalised in ICU, bilateral pulmonary infiltration in chest X‐ray or CT‐scan; respiratory distress with > 24 breaths per minute | Inpatient | Hydrocortisone, methylprednisolone, dexamethasone | IV | 81 | Completed |
IRCT20160118026097N4 | Ghoum University of Medical Sciences | RCT | Middle‐income country (Iran) |
Hypoxia requires supplemental oxygen to maintain oxygen saturation > 90% | Inpatient | Dexamethasone | Not stated | 64 | Completed |
IRCT20200611047727N3 | Shahid Beheshti University of Medical Sciences | RCT | Middle‐income country (Iran) | Oxygen saturation level < 93 | Inpatient | Methylprednisolone | IV | 60 | Completed |
IRCT20201015049030N1 | Teheran University of Medical Sciences | RCT | Middle‐income country (Iran) | Blood oxygen saturation between 90% and 95% | Outpatient | Dexamethasone | Not stated | 200 | Completed |
ISRCTN33037282 |
Clínica Medellín ‐ Grupo Quirónsalud | RCT | Middle‐income country (Colombia) |
PaO2 ≤ 60 mmHg or SpO2 ≤ 90% or on HFNC, CPAP or NPPV at randomisation Excluded: on IMV |
Inpatient | Methylprednisolone, dexamethasone | IV | 680 | Completed |
NCT04244591 | Peking Union Medical College Hospital | RCT | Middle‐income country (China) | PaO2/FiO2 < 200 mmHg; positive pressure ventilation (non‐invasive or invasive) or HFNC > 45 L/min for < 48 h; requiring ICU admission | Inpatient | Methylprednisolone | Not stated | 80 | Completed |
NCT04325061 | Dr. Negrin University Hospital | RCT | High‐income country (Spain) | Intubated and mechanically ventilated | Inpatient | Dexamethasone | IV | 19 | Terminated (lack of enrolment) |
NCT04530409 | ClinAmygate | RCT | Middle‐income country (Egypt) |
Mild and moderate severity | Unclear | Dexamethasone | Unclear, most likely systemic | 450 | Completed |
NCT04746430 | General Practitioners Research Institute | RCT | High‐income country (Netherlands) | Exercise‐induced desaturation, defined as SpO2 < 92% (< 90% for COPD patients) and/or an absolute drop of ≥ 4% in SpO2 after a 1‐min sit‐to‐stand test or SpO2 < 92% (< 90% for COPD patients) at rest with GP's and patient's shared decision to keep patient at home despite this in itself being an indication for referral to hospital | Outpatient | Dexamethasone | Unclear, most likely systemic | 2000 | Terminated (too few patients) |
EUCTR2020‐002186‐34‐ES | Fundació Hospital Universitari Vall d'Hebron ‐ Institut de Recerca (VHIR) | RCT | High‐income country (Spain) | Air oxygen saturation > 90 and < 94%; PaO2/FiO2 > 200 and ≤ 300 mmHg; Sa:FiO2 (O2 saturation measured with pulse oximeter/inspired O2 fraction) ≤ 350 | Inpatient | Methylprednisolone | IV | 100 | Prematurely ended |
EUCTR2020‐004323‐16 |
Azienda Ospedaliera Arcispedale Santa Maria Nuova/IRCCS di Reggio Emilia | RCT | High‐income country (Italy) | Need for supplemental oxygen in any delivery mode with the exception of IMV | Inpatient | Methylprednisolone | IV | 260 | Completed |
NCT04347980 | Centre Chirurgical Marie Lannelongue | RCT | High‐income country (France) | Admitted to ICU | Inpatient | Dexamethasone | IV | 122 | Terminated (ANSM (Agence nationale de sécurité du médicament et des produits de santé) Recommendation) |
NCT04438980 | Fundacion Miguel Servet | RCT | High‐income country (Spain) | Hospitalised Excluded: SpO2 < 90% (in air ambient) or PaO2 < 60 mmHg (in ambient air) or PaO2/FiO2 < 300 mmHg |
Inpatient | Methylprednisolone | IV | 72 | Completed |
NCT04451174 | University of Chile | RCT | High‐income country (Chile) | Excluded: requirements of mechanical ventilation (IMV/NIV) Included: oxygen requirements until 35 % by Venturi mask or 5 L/min by nasal cannula |
Inpatient | Prednisone | IV | 184 | Terminated (corticosteroid use approval) |
Salukhov 2021 | Not stated | RCT (unclear randomisation process) | Middle‐income country (Russia) | Moderate to severe course with process prevalence according to computed tomography without hypoxaemia (saturation SpO2 > 93%) with a duration of hyperthermia > 38 °C for 3 days or more and C‐reactive protein levels of 15 to 50 mg/L | Inpatient | Methylprednisolone | oral | 40 | Completed and published (but unclear randomisation process) |
Ghanei 2021 | Not stated | RCT | Middle‐income country (Iran) | Oxygen saturation (Spo2) less than 94% | Inpatient | Prednisolone | Not stated | 236 | Completed and published (not pre‐registered, no ethics vote named, no patient informed consent) |
Gautam 2021 | None | RCT | Middle‐income country (India) | Moderate to severe COVID‐19, oxygen saturation < 93% on room air | Inpatient | Methylprednisolone, dexamethasone | IV | 140 | Completed and published (not pre‐registered, no ethics vote named, no patient informed consent, no information about randomisation) |
Montalvan 2021 | Not stated | RCT (unclear randomisation process) | Middle‐income country (Honduras) |
Not stated | Inpatient | Dexamethasone | Not stated | 81 | Completed and abstract published (no registration number, no information about randomisation process), only abstract available |
Rashad 2021 | South Valley University | RCT (unclear randomisation process) | Middle‐income country (Egypt) | Moderate to severe ≥ 5 | Inpatient | Dexamethasone | IV | 149 | Completed and published (no pre‐registration, unclear randomisation process) |
ARDS: acute respiratory distress syndrome; COPD: chronic obstructive pulmonary disease; CT: computed tomography; HFNC: high‐flow nasal cannula;ICU: intensive care unit; RCT: randomised controlled trial; RT‐PCR: reverse transcription polymerase chain reaction. |