Immunological, Mental and Physical After-effects of COVID-19 infection

In the first half of 2020, the Netherlands was hit by the first wave of
COVID19, with many patients receiving care for this at the OLVG. In a specially
activated outpatient clinic, more than 450 people were seen, as part of
aftercare, who had experienced this infection.
It is currently unclear whether, and if so, to what extent people will be left
with residual damage after a COVID19 infection. Furthermore, there is still
uncertainty about the duration and effectiveness of the acquired immunity,
which should protect the patient against possible new infections with
SARS-CoV2. When a so-called 2nd wave COVID19 occurs, these patients fear that
they could become ill again
Through this study protocol, we want to follow up this patient group
prospectively for a period of at least 1 year, with a focus on quality of life
and its recovery (both mental and physical) in the follow-up period, the
occurrence of a new infection. with SARS-CoV2, as well as for the preservation
of the specific anti-SARS-CoV2 antibodies that developed during the COVID19
period.

Primary research objective
To describe the recovery of physical and mental quality of life after a COVID19
infection

Secondary research objectives:
1. Investigate the incidence of SARS-CoV2 re-infections during follow-up
expressed in number of cases per 100 person-years of follow-up
2. Investigate any further improvement in lung function at 6, 12 and 18-24
months
3. Investigate mortality and cause of death after recovery of 1st COVID19
4. Investigate the course of antibody response against SARS-CoV2 after COVID19
5. Analyze possible association of the various patient characteristics (sex,
age, comorbidity, medication use, intoxications and severity of COVID19) and
the primary and secondary outcomes at 6, 12 and 18-24 months

All potential participants were seen at the outpatient clinic around 3 months
after their COVID19 infection as part of the COVID19 care program. Around that
time, the consequences of the COVID19 were systematically recorded during the
care process, with specific attention to mental and physical well-being (by
means of questionnaires) as well as to damage to the lung (by means of lung
function and X-ray examination). All patients were investigated for antibody
development by blood sampling around 4 weeks after disease presentation. Some
of the patients remained in the care of a lung specialist if there was a
reduced lung function and / or radiological abnormalities were still present,
the other part was referred back to primary care. All patients were asked if
they could be approached for a prospective follow-up study
During a prospective follow-up study, in case of new symptoms, all patients
will be advised to be re-tested for infection with the SARS-CoV2 virus by a
general practitioner and / or municipal healthcare service, and to report a
positive finding to the OLVG research team. Furthermore, at month 6, 12 and
18-24 after the start of the care process at the time of the COVID19 period (T
= 0), the quality of life will be evaluated by means of validated
questionnaires (SF36, HADS, PCL-5 and ICI), as well will they be asked about
clinical events that have occurred. With prior permission, further information
may be obtained from their general practitioner with regard to diagnoses made
or if the patient no longer responds to evaluation requests. In addition, a new
serum tube will be taken from all patients at 6 and 12 months to determine the
antibody titer against SARS-CoV2; this result will be compared with the values
**at T = 0 and T = 5 weeks.
Of all patients who remained in care with a pulmonologist after 3 months,
change (improvement?) In lung function and radiological abnormalities will be
analyzed

The burden is limited, since for all participants the only additional burden is
a venipuncture taken twice to obtain a serum sample (with the risk of
bruising), as well as the fulfillment of the above-mentioned questionnaires
(also twice).
Through the study, participants are actively involved in acquiring new
information on the new infection COVID19, actively considering their own health
and being informed about the degree of permanent sero-immunity (much of which
is still unclear at this point)