Treatment for Moderate/Severe COVID-19 in a Fragile and Vulnerable Population, Admitted to a Geriatric Hospital Unit or in a Transicional Care Center

Inclusion Criteria:

1. Be at least 65 years old and be admitted to the Geriatrics Unit of the Internal
Medicine Service (Hospital Clínic de Barcelona) or to a transicional care center

2. Clinical diagnosis compatible with COVID-19 (in a favourable epidemiological context),
with a disease considered moderate (grade 3-4) or severe (grade 5) according to the
WHO 8-point ordinal scale for assessing clinical severity
(https://www.who.int/publications/i/item/covid-19-therapeutic-trial-syno…). This
same scale will also be used to evaluate the evolution after the application of the
corresponding treatment. Baseline clinical parameters will include the presentation of
fever and any respiratory symptoms, both of upper respiratory tract and dyspnea,
affecting the general state or gastrointestinal manifestations, since it is known that
in elderly people the COVID-19 can present with atypical symptoms for a time that is
difficult to determine, but it also tends to evolve to respiratory failure quickly and
is associated with high mortality. For this reason, regardless of the time that has
elapsed since the estimated onset of symptoms, patients with moderate - WHO grade 3,
in whom the presence of fever, mild dyspnea or any gastrointestinal manifestation
attributable to COVID-19 make an admission (in the case of hospital) and directed
treatment (in all cases) advisable, will be candidates for inclusion in the study.
Patients with moderate disease and oxygen requirements (WHO grade 4) and patients with
severe pneumonia, but who can be managed initially with high flow oxygen therapy (WHO
grade 5) may also be included in the study. The clinical diagnosis may be supported by
radiological changes (via chest radiography, if available) suggestive of bilateral
(established or incipient) pneumonia. At the time of diagnosis, biomarkers will also
be collected, in an analysis that will include increased levels of C-reactive protein
[PCR] and/or ferritin and microbiological confirmation of SARS-CoV-2.

3. Patients in whom the current clinical situation and the basal functional situation
condition a prognosis that makes them consider a limited therapeutic ceiling, which
includes the contraindication of applying more aggressive (e.g. non-invasive
ventilation) or invasive measures (e.g. cardiopulmonary resuscitation or orotracheal
intubation and mechanical ventilation), both in patients admitted to the Geriatric
Unit (Hospital Clínic de Barcelona) and in those admitted to a transicional care
center. The latter patients are also not considered for transfer to a third level
hospital (according to the criteria of fragility, available on page 14 of the CatSalut
action protocols
(https://canalsalut.gencat.cat/web/.content/_A-Z/C/coronavirus-2019-ncov…
lgatiu/recull-protocol-pneumonia.pdf).

4. Patient with a general condition that allows him/her to take the medication orally,
without risk of bronchial aspiration.

5. Acceptance by the patient or responsible family member to participate in the study
(written consent).

Exclusion Criteria:

1. The clinical situation of an advanced or terminal illness, according to the clinical
judgment of the doctor in charge and as defined by the Spanish Society for Palliative
Care (SECPAL), which describes it as an advanced illness in an evolutionary and
irreversible phase with multiple symptoms, emotional impact, loss of autonomy, with
very little or no capacity to respond to specific treatment and with a life expectancy
limited to weeks or months, in a context of progressive fragility
(http://envejecimiento.csic.es/documentos/documentos/navarro-cuidadospal…
).

2. Clinical status which is advanced and severe or in which the level of consciousness
has deteriorated and the oral route of taking the medication is not safely tolerated
(in the opinion of the doctor in charge)

3. Taking any of the drugs in the trial (colchicine or prednisone) chronically or
intermittently in the 7 days prior to study inclusion.

4. Absolute contraindication to the use of the study medication, including
hypersensitivity to the active substance or to any of its excipients, severe renal
failure (glomerular filtration [GF] creatinine clearance or Clcr <30 ml/min) and
patients undergoing haemodialysis, severe liver failure, severe gastrointestinal
disorders, gastric ulcer or blood dyscrasias.

5. Concomitant treatment with macrolides (clarithromycin, erythromycin, telithromycin),
antifungals (itraconazole, ketoconazole), cyclosporine and antivirals
(lopinavir/ritonavir, indinavir, nelfinavir, saquinavir), all potent inhibitors of
CYP3A4 (key cytochrome in the colchicine metabolism pathway).