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. 2022 Nov 17;2022(11):CD014963. doi: 10.1002/14651858.CD014963.pub2

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.