Participants and study protocol
This epidemiological
cross-sectional-analytical study
was conducted at Abadan University of Medical Sciences, Abadan,
Khuzestan Province, Iran. With the coordination between the
vice-chancellor for education and the vice-chancellor for health of
Abadan University of Medical Sciences, a list of outpatients was
obtained from the deputy minister of health. Patients on the list had
been referred to 16-hour comprehensive health centers in Abadan for
COVID-19 PCR testing between the beginning of April and the end of July
2020 and had definitive (negative/ positive) PCR results.
By telephone contact with these outpatients, those who met the criteria
for inclusion (all ages, male and female gender) in the study and
provided informed consent to participate were selected and assigned to
two groups: negative and positive PCR (N= 52 in each group).
The study protocol was approved by the Ethics Committee of Abadan
University of Medical Sciences (Ethics Code: IR.ABADANUMS.REC. 1399.079)
following the Declaration of Helsinki for medical research involving
human subjects. Outpatients with known hypothalamic, pituitary, adrenal,
or severe hepatic diseases—as well as those on corticosteroid
treatment or other medications affecting adrenal function—in the
preceding three months, were excluded. Also, those who had known RAAS
disorders or were on any medications which interfere with the activity
of this system during the three last months were excluded. Also,
pregnancy and lactation in women, unclear PCR test results, PCR testing
for the second time, smoking during the test period, high-risk jobs
including healthcare staff and public transport drivers (for the control
group) were grounds for exclusion, as were any other circumstances that
the researcher did not consider to justify the participation of
individuals.
With prior coordination, the participants were referred to Imam Khomeini
Health Center. All participants were asked to go to the Imam Khomeini
Center in a fasting state between 7:00 a.m. and 9:00 a.m. Patients’
medical histories were retrospectively reviewed, and their demographic
information (age and sex) and clinical data (respiratory rate, pulse
rate, SPO2) were collected. Also, the participant’s clinical symptoms
were recorded in four groups of symptoms: general (fever, fatigue, night
sweats, shivering, and asthenia), respiratory (cough and dyspnea),
gastrointestinal (nausea, constipation, and diarrhea), and neurologic
(muscle/joint pain, loss of taste/smell, headache)(11) via self-reports.
The participants were then referred to the Abadan Private Health
Laboratory, where a blood sample was collected from each person and
stored for biochemical tests. Routine laboratory investigations were
performed within the first 24 hours after laboratory admission. These
included blood groupings using commercially prepared monoclonal anti-A,
anti-B, and anti-D antisera (Agappe Diagnostics Ltd., India), assessment
of serum levels of cortisol (Cortisol ELIZA Kit; Monobind Inc.), and
serum levels of aldosterone (Aldosterone ELIZA Kit; Monobind Inc.). The
day of referral to Imam Khomeini Health Center was considered the first
day of the study for each person. The clinical symptoms of PCR-positive
outpatients were followed up with and recorded over 28 days (in one-week
intervals) by telephone.