The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study

Table 2 Schedule of visits and assessments at different points of the study protocol

Assessments	Study period
	Screening	Visit 1 (day 10) ± 3 days	Visit 2 (day 21) ± 3 days	Visit end (day 61) ± 3 days
	Screening	The visits are made by telephone call every 48 h and face-to-face visits on the 10th day and 21st day of the treatment and monthly until the end of the patient in the study.
Informed consent form	x
Randomization	x
Medical history	x	x	x	x
Vital signs	x	x	x	x
Physical examination	x
Diagnostic PCR	x
Blood analysis	x*	x	x
Treatment of the clinical trial		x	x
Concomitant medication, including vaccination schedule	x	x	x	x
Adverse events		x	x	x

ISSN: 1745-6215