COVID-19 trials registries data warehouse

Datawarehouse codebook


Trial data

Trial registration number

Data type : text
Description
Identifiant number of the trial in the registry

Full text link

Data type : url
Description
Link to trial registration

First author

Data type : text
Description
Name of principal investigator or contact person of the trial

Contact

Data type : text
Description
Email of principal investigator or contact person of the trial

Registration date

Data type : text
Description
Date of trial registration in the registry

Recruitment status

Data type : rel
Description
Status of recruitment, receiving the following values:
  • Not recruiting: the trial has not started the recruitment yet
  • Recruiting: the trial has started the recruitment
  • Completed: the trial has recruited enough participants as planned
  • Terminated: the trial has terminated early without achieving the planned sample size, and will not resume the recruitment
  • Suspended: the trial has stopped the recruitment temporally and might resume recruitment later
  • Withdrawn: The study stopped early, before enrolling its first participant

Study design

Data type : rel
Description
Summary of study design whether it is RCT or nonRCT (only for vaccine trials)

Allocation

Data type : rel
Description
Record if the allocation is Randomized or Non-randomized (only for non-randomized vaccine studies)

Design

Data type : rel
Description
Summary of study design whether it is parallel, adaptive, factorial, sequential, cluster, crossover or single group assignment (only for vaccine trials)

Masking

Data type : rel
Description
Record whether participants are blinded to treatment assigned. Not reported if no information provided

Center

Data type : rel
Description
Record whether the trial is single-center or multiple-center. Unclear if no information provided

Study aim

Data type : rel
Description
Record the purpose of the intervention: Prevention, Treatment or Long covid

Inclusion criteria

Data type : text
Description
Record the criteria to include participants in the trial

Exclusion criteria

Data type : text
Description
Record the criteria to exclude participants in the trial

Number of arms

Data type : text
Description
Number of treatment arms evaluated in the trial

Funding

Data type : text
Description
Name of sponsor as reported in trial registration

Inclusion age min

Data type : int
Description
Minimum age of participants to be included in the trial

Inclusion age max

Data type : int
Description
Maximum age of participants to be included in the trial

Countries

Data type : text
Description
The countries where the trial is conducted as reported in trial registry. Not reported if no information provided

Type of patients

Data type : rel
Description
For prevention trial:
  • Write 'Close contacts to covid patients' if trials test prevention for participants who have contact with covid patients
  • Write 'Health workers' if trials test prevention for health workers
  • Write 'Healthy volunteers' if trials recruit healthy volunteers (i.e. vaccine trials)
  • Write 'High risk patients' if trials recruit only elderly or people of any age who are at increased risk of severe illness from COVID-19
For treatment trials :
  1. Check online protocol (mainly described in the section 'inclusion criteria') for severity as classified according to the following criteria:
    • Mild - the clinical symptoms are mild with no sign of pneumonia on imaging
    • Moderate - patients have fever and respiratory symptoms with radiological findings of pneumonia and requiring oxygen (3L/min>Oxygen <5L/min)
    • Severe (cases meeting any of the following criteria) - Respiratory distress ≧30b/m; O2Sats ≤ 93% at rest in ambient air or O2Sats ≤97 % with O2 > 5L/min; PaO2/FiO2 ≦ 300 mmHg (l mmHg=0.133kPa). PaO2 / FiO2 in high-altitude areas (at an altitude of over 1,000 meters above the sea level) shall be corrected by the following formula: PaO2/ FiO2 x [Atmospheric pressure (mmHg)/760]; Chest imaging showing obvious lesion progression within 24-48 hours)
    • Critical (cases meeting any of the following criteria): Respiratory failure and requiring mechanical ventilation; shock; other organ failure that requires ICU care).
  2. Report disease severity at enrollment, except for therapeutic vaccine trials then write only 'infected patients':
    • 'No restriction on type of patient': for trials which do not specify type of patients to be included
    • 'Mild disease at enrollment' : for trials with asymptomatic and/or mild patients to be included
    • 'Mild/moderate disease at enrollment': for trials with both mild and moderate patients to be included
    • 'Moderate disease at enrollment'
    • 'Moderate/severe disease at enrollment': for trials with both moderate and severe patients to be included
    • 'Moderate/severe/critical disease at enrollment': for trials with moderate, severe and critical patients to be included
    • 'Severe disease at enrollment'
    • 'Severe/critical disease at enrollment': for trials with both severe and critical patients to be included
    • 'Critical disease at enrollment'
For long covid treatment trials :
  • Write 'Patients recovered from covid'

Severity scale

Data type : rel
Description
Report the corresponding number on the severity scale according to the previous 'type of patients column' as follows:
  • 0: No restriction on type of patients
  • 1: Mild disease at enrollment
  • 2: Mild/moderate disease at enrollment
  • 3: Moderate disease at enrollment
  • 4: Moderate/severe disease at enrollment
  • 5: Moderate/severe/critical disease at enrollment
  • 6: Severe disease at enrollment
  • 7: Severe/critical disease at enrollment
  • 8: Critical disease at enrollment
  • N/A if study aim is prevention or long covid

Total sample size

Data type : int
Description
Total target number of participants randomized in the trial

primary outcome

Data type : text
Description
Primary outcomes as reported in trial registry

Notes

Data type : text
Description
If same treatment in different arms, to help distinguish them, note here any difference retrieved from the protocol in:
  • population (disease severity, subgroup)
  • treatment:
    • doses (if different in dose: write dose 1, dose 2)
    • administration route (if different in administration route write IV, PO, SC correspondingly)
    • duration
    • treatment frequency
Note any other general remarks E.g. unclear number of arms

Phase

Data type : rel
Description
Phase of trial: Phase 1, Phase 1/Phase 2, Phase 2, Phase2/Phase 3, Phase 3, Phase 3/Phase 4, Phase 4 and Not reported if no information is provided

Arms

Data type : json
Description
Gathers each interventional trial arm characteristics (treatment name, treatment type, treatment type order treatment category, n randomized in this arm, arm notes)

Arms data

Treatment name

Data type : text
Description
Name of treatment as reported in the intervention section

Treatment type

Data type : text
Description
Use predefined terminology updated each week as necessary. If 'Standard of care' or 'Placebo' in the previous treatment name column, duplicate this information here.

Treatment category

Data type : text
Description
Specify if the intervention is a: 'Pharmacological treatment', 'Non pharmacological treatment', 'Biological treatment', 'Non covid vaccine', 'Vaccine', 'Standard of care' or 'Placebo'

Arm Notes

Data type : text
Description
Contain additional information regarding each trial arm to guide annotators during data checking activity.