Table 1 General characteristics of the included trials
From: Therapeutic role of corticosteroids in COVID-19: a systematic review of registered clinical trials
Trial identifier | Country | Number of sites | Start date | Expected completion date | Stage of COVID-19 | Outcome measures |
|---|---|---|---|---|---|---|
NCT04425863 | Argentina | Single | May 2020 | July 2020 | Severe acute respiratory syndrome | 1. Illness development 2. Reduction of ICU admission 3. Mortality rate |
NCT04395105 | Argentina | Multi | May 2020 | January 2021 | Respiratory distress syndrome | Ventilator-free days at 28 days |
NCT02735707 | Australia, Belgium, Canada, Croatia, Germany, Hungary, Ireland, Netherlands, New Zealand, Portugal, Romania, Spain, UK | Multi | April 2020 | December 2023 | Pneumonia | 1. All-cause mortality 2. Days alive and outside of ICU |
NCT04343729 | Brazil | Single | April 2020 | September 2020 | Severe acute respiratory syndrome (SARS) | Mortality rate |
NCT04327401 | Brazil | Multi | April 2020 | August 2020 | Moderate/severe ARDS | Ventilator-free days |
NCT04377503 | Brazil | Not available | May 2020 | November 2020 | Cytokine release syndrome | Patient clinical status 15 days after randomization |
NCT04374474 | Canada | Single | January 2021 | March 2022 | Not defined | 1. Change from Baseline Snap and Sniff Threshold Test at 3 months 2. Score from the Snap and Sniff Olfactory Test results 3. Change from baseline Smell Identification Test (SIT) at 3 months 4. Score from the Smell Identification test results. 5. Change from Baseline Snap and Sniff Threshold Test at 6 months 6. Score from the Snap and Sniff Olfactory Test results 7. Change from baseline Smell Identification Test (SIT) at 6 months |
NCT04263402 | China | Not available | February 2020 | July 2020 | Severe pneumonia | 1. Rate of disease remission 2. Rate and time of entering the critical stage |
NCT04244591 | China | Completed | January 2020 | April 2020 | Severe acute respiratory failure | Murray lung injury score |
NCT04273321 | China | Completed | February 2020 | April 2020 | Pneumonia | The incidence of treatment failure in 14 days |
ChiCTR2000029386 | China | Single | January 2020 | January 2021 | Pneumonia | SOFA score |
ChiCTR2000029656 | China | Single | February 2020 | April 2020 | Pneumonia | ECG, chest imaging, complications, vital signs, and NEWS2 score |
ChiCTR2000030481 | China | Multi | January 2020 | April 2020 | Pneumonia | The time of duration of COVID-19 nucleic acid RT-PCR test results of respiratory specimens (such as throat swabs) or blood specimens change to negative |
NCT04348305 | Denmark | Multi | April 2020 | December 2021 | COVID-19 hypoxia | Days alive without life support at day 28 |
2020-001395-15 | Denmark | Multi | April 2020 | Not available | Severe hypoxia | 1. Days alive without life support (i.e., invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomization to day 28). |
NCT04331054 | France | Multi | April 2020 | July 2020 | COVID-19 infection | Time (in days) to clinical improvement within 30 days after randomization |
NCT04361474 | France | Multi | May 2020 | May 2021 | Hyposmia | Patient with more than 2 points on the ODORATEST |
NCT04359511 | France | Not available | June 2020 | December 2020 | Pneumonia | Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days |
NCT04347980 | France | Multi | April 2020 | August 2020 | Acute respiratory distress syndrome (ARDS) | 28-day mortality |
NCT04344730 | France | Single | April 2020 | December 2020 | Pneumonia | 1. Time-to-death from all causes within the first 60 days after randomization 2. Time to need for mechanical ventilation |
NCT04344288 | France | Multi | April 2020 | November 2020 | Pneumonia | Respiratory indication for transfer to intensive care unit evaluated by a SpO2 < 90% |
NCT04331470 | Iran | Single | April 2020 | May 2020 | Not defined | Clear chest CT scan and PCR test |
IRCT20200204046369N1 | Iran | Multi | Not available | Not available | Not defined | PAO2/FiO2 through ABG method |
IRCT20151227025726N17 | Iran | Single | Not available | Not available | ARDS | 1. Daily need for invasive mechanical ventilation 2. Death at the end of the study |
IRCT20120225009124N4 | Iran | Single | Not available | Not available | Not defined | Improvement in SpO2 measured by pulse oximeter |
IRCT20200406046963N1 | Iran | Single | Not available | Not available | ARDS( acute respiratory distress syndrome) | 1. Mortality rate after 60 days 2. Blood O2 saturation measurement 3. Need for oxygen therapy |
IRCT20200404046947N1 | Iran | Multi | Not available | Not available | Not defined | 1. Findings on the CT scan 2. Mortality rate 3. O2 saturation levels 4. Need an oxygen therapy at day 3 and discharge time |
IRCT20081027001411N3 | Iran | Multi | Not available | Not available | ARDS | 1. Findings on the CT scan 2. Mortality rate 3. O2 saturation levels 4. Need an oxygen therapy at day 3 and discharge time |
IRCT20120215009014N354 | Iran | Single | Not available | Not available | Mild-to-moderate acute respiratory distress syndrome | 1. Need to mechanical ventilation 2. The patient’s clinical status 3. Mortality rate |
IRCT20080901001165N52 | Iran | Single | Not available | Not available | Moderate to severe pneumonia | Need to receive ICU service |
NCT04323592 | Italy | Single | March 2020 | May 2020 | Acute respiratory distress syndrome | 1. Admission to ICU and need for Invasive mechanical ventilation 2. In-hospital death within 28 days 3. Endotracheal intubation |
KCT0005105 | Korea | Multi | April 2020 | September 2020 | Mild | Rate of SARS-CoV-2 eradication at day 14 from study enrollment |
IRCT20200318046812N2 | Iran | Multi | Not available | Not available | Not defined | Admission to intensive care unit |
NCT04345445 | Malaysia | Single | April 2020 | October 2020 | Pneumonia | 1. The proportion of patients requiring mechanical ventilation 2. Mean days in ventilation |
NCT04360876 | Not available | Single | May 2020 | December 2020 | ARDS | Ventilator-free days (VFD) at day 28 |
NCT04366115 | Not available | Not available | June 2020 | June 2023 | Not defined | 1. Dose-limiting toxicities 2. 28-day all-cause mortality for phases 1 and 2 |
NCT04435795 | Not available | Not available | June 2020 | March 2021 | Not defined | Improvement in dyspnea at day 7 |
NCT04355247 | Puerto Rico | Multi | April 2020 | April 2021 | High-risk COVID-19 | 1. Clinical complete response criteria 2. Need for ventilatory support 3. O2 Saturation of >/= 93% by day 14 of therapy 4. Mortality at day 28 5. Findings on CT chest on day 28 |
NCT04438980 | Spain | Multi | May 2020 | February 2021 | Pneumonia | 1. Proportion of patients developing treatment failure 2. Need for mechanical ventilation 3. Decrease in SpO2 < 90% (in ambient air) or PaO2 < 60 mmHg (in ambient air) or PaO2FiO2 < 300 mmHg |
NCT04394182 | Spain | Multi | April 2020 | April 2021 | Pneumonia | Oxygen saturation at day 2 |
NCT04380818 | Spain | Multi | June 2020 | July 2021 | Pneumonia | Efficacy of low-dose pulmonary irradiation assessed by change in PAFiO2 by 20% |
NCT04355637 | Spain | Multi | April 2020 | October 2020 | Pneumonia | Proportion of patients developing treatment failure |
NCT04341038 | Spain | Single | April 2020 | June 2020 | Severe lung injury secondary to COVID-19 | Time to reach clinical stability |
NCT04329650 | Spain | Multi | April 2020 | May 2020 | Pneumonia | Proportion of patients requiring ICU admission at any time within the study period |
NCT04325061 | Spain | Multi | April 2020 | October 2020 | ARDS | 60-day mortality |
2020-001827-15 | Spain | Single | Not available | Not available | Pneumonia | 1. Proportion of patients with treatment failure up to 14 days after randomization 2. Mortality rate 3. ICU admission 4. Number of patients requiring mechanical ventilation 5. Clinical deterioration/worsening, defined as decrease in SpO2 below 90% or PaO2 below 60 mmHg in ambient air + radiological progression. |
2020-001622-64 | Spain | Single | April 2020 | Not available | Not defined | 1. Measurement of O2 saturation and/or blood gas, findings on chest x-ray, CBC, including inflammatory markers and blood biometrics, and ECG 2. 30-day ICU admission and hospital stay 3. Outbreaks of steroid-related psychosis |
2020-001934-37 | Spain | Multi | May 2020 | Not available | Not defined | 1. Mortality rate 2. Number of days of ICU stay 3. Number of patients requiring non-invasive ventilation (NIV) |
2020-001413-20 | Spain | Single | April 2020 | Not available | Pneumonia | Proportion of patients requiring ICU admission at any time within the study period |
2020-001445-39 | Spain | Single | March 2020 | Not available | Pneumonia | Time (days) to clinical stability after initiation of trial treatment for severe pneumonia secondary to COVID-19 and elevated inflammatory parameters |
2020-001307-16 | Spain | Single | April 2020 | Not available | ARDS | Death from any cause in the first 28 days after randomization |
NCT04381364 | Sweden | Multi | May 2020 | December 2020 | Pneumonia | Duration of supplemental oxygen therapy |
NCT04416399 | UK | Not available | June 2020 | December 2020 | Early infection | Emergency department visit related to COVID-19 |
NCT04381936 | UK | Multi | March 2020 | June 2021 | SARS | All-cause mortality |
NCT04411667 | USA | Multi | April 2020 | November 2020 | Not defined | Number of subjects requiring mechanical ventilation |
NCT04377711 | USA | Multi | June 2020 | December 2020 | Symptomatic COVID-19 infection | Percentage hospital admission or death by day 30 |
NCT04349410 | USA | Not available | April 2020 | November 2020 | Pneumonia | 1. Improvement in FMTVDM measurement with nuclear imaging 2. Ventilator status 3. Extubation status 4. Survival status in 30 days |
NCT04193878 | USA | Multi | June 2020 | June 2024 | Pneumonia, acute respiratory failure | Number of patients with acute respiratory failure (ARF) within 10 days of randomization |
NCT03852537 | USA | Single | December 2019 | July 2022 | Pneumonia | 1. Feasibility of the timely initiation of corticosteroids and implementation of biomarker-titrated corticosteroid dosing 2. Percentage of eligible patients adhered to the timely initiation within 30 days |
NCT04374071 | USA | Completed | March 2020 | April 2020 | Pneumonia | 1. Number of patients transferred to ICU is each of the group 2. Number of patients requiring mechanical ventilation 3. Mortality rate |