This study proposal aims to determine whether early corticosteroid treatment can reduce the need for oxygen therapy and post-COVID sequelae
Description of the Study Proposal:
- Title: Early treatment with corticosteroids and the decrease in the incidence of hypoxemia due to COVID-19.
- Principal Investigator: Anna Puigdellívol Sánchez.
- Study Type: Retrospective descriptive study.
- Design: Ambispective.
– Variables: Age, sex, saturation on day 0-14. Pathological auscultation, corticoid dose received, previous pathologies, previous treatments, previous anticovid vaccination (including type), hospitalisation, date of admission, date of discharge, ICU use, X-ray compatible with Covid19, CT scan results (if available).
1 – Description of the variables of the cases registered in the weeks prior to the start of the study.
2 – In any suspicious case attended:
– Determination of basal saturation with pulse oximeter at the time of suspected COVID (dysthermia, arthromyalgia, cough, vomiting or diarrhoea). Auscultation.
– Referral according to saturation or auscultation.
– In case of no referral:
* Recommendation for the purchase of a pulse oximeter or its delivery, if the mechanism is articulated in the near future (return to the centre after overcoming the disease).
* Treatment with corticosteroids according to saturation and auscultation results (see next page).
3 – Prospective quantification of the rate of hospitalisation and/or need for oxygen therapy (desaturation below 95%), stratified by age.
– Comparison with the rate of hospitalization from July 1th until the beginning of the study.
Proposed action according to SATURATION:
* Roth test every 2 hours (count out loud up to 30; if impossible more than 8 seconds, saturation 95%) Reassessment at any time if changes.
* Saturation check every 8 hours.
– 96% Start corticosteroids:
* Adults: (if obese, prior determination of glycaemia cailar; if glycaemia <200. If glycaemia > treat diabetes additionally): Prednisone 30 mg 1 committed/day x 7 days and then descending schedule x 3 days.
* Children: Prednisolone (Stilsone) 0.5 mg/kg every 12 hours. Roth test every 2 hours. Reassessment if not exceeded, at the time of occurrence. Saturation every 8 hours.
– ≤95% Hospital referral.
Objectives of the Study Proposal:
Hypothesis: Early corticosteroid treatment may reduce the need for oxygen therapy and post-COVID sequelae.
Principal Objective: Reduction of the need for oxygen therapy and post-COVID sequelae.
Secondary Objective: Reduction of hospitalisations due to COVID-19.
More about this Study Proposal:
Background: Early corticosteroid treatment has been shown to be efficient in reducing hospital stay (1) and has been used to decrease cytokine storm (2) reducing intubation needs and mortality (3), while some previous studies related to SARS, MERS and influenza point to its possible iatrogenicity producing psychosis, diabetes and secondary infections, among others (4). Although corticosteroid use has been linked to other fungal infections (5,6), these have occurred 14 days after hospitalisations in the most severe cases. In parallel, there is preliminary evidence of the efficacy of other treatments, such as antihistamines, which may have decreased the cytokine storm (7).
Preliminary data from study NCT04367883, (ref CST 02-20-161-021), initiated in April 2020 to evaluate the efficacy of cross-protection with influenza vaccine, IECAS and ARA2 (8) suggested that the need for hospitalisation may be as high as 1:10-20 among those over 50 years of age (9). There is also experience in characterising COVID patients in primary care (10).
There is currently no evidence on whether early use of corticosteroids, when an initial decrease in saturation is detected, could reduce hospitalisations and subsequent sequelae.
Limitations of the Study:
– The work plan needs to be finalised with frontline professionals.
– The attached proposal should not be considered a protocol or a substitute for a medical assessment. The medical staff is directly responsible for the treatment decision based on examination and diagnostic impression.
(1). Fadel R, Morrison AR, Vahia A, Smith AR, Chaudhry Z, Bhargava P, Miller J, Kenney RM, Alangaden G, Ramesh MS. Early Short-Course Corticosteroids in Hospitalized Patients With COVID-19 . Clin Infect Dis. 2020; 71(16): 2114-2120. doi: 10.1093/cid/ciaa601.
(2). Sun X, Wang T, Cai D, Hu Z, Chen J, Liao H, Zhi L, Wei H, Zhang Z, Qiu Y, Wang J, Wang A. Cytokine storm intervention in the early stages of COVID-19 pneumonia. Cytokine Growth Factor Rev. 2020 Jun;53:38-42. doi: 10.1016/j.cytogfr.2020.04.002.
(3) Callejas-Rubio JL, Luna Del Castillo JdD, de la Hera-Fernández J, Guirao-Arrabal E, Colmenero-Ruiz M, Ortego-Centeno N. Effectiveness of corticoid pulses in patients with cytokine storm syndrome induced by SARS-CoV-2 infection. Med.Clin.(Barc). 2020 Aug 28;155(4):159-161. doi: 10.1016/j.medcli.2020.04.018.
(4) L.J. Stockman, R. Bellamy, P. Garner, SARS: systematic review of treatment effects, PLoS Med. 3 (9) (2006) e343.
(5) Song G, Liang G, Liu W. Fungal Co-infections Associated with Global COVID-19 Pandemic: A Clinical and Diagnostic Perspective from China. Mycopathologia. 2020 Aug;185(4):599-606. doi: 10.1007/s11046-020-00462-9. Epub 2020 Jul 31.
(6) Garg D., Muthu V, Singh Sehgal IS, Ramachandran R, Kaur H, Bhalla A, Puri GD, Chakrabarti A, Agarwal R. Coronavirus Disease (Covid-19) Associated Mucormycosis (CAM): Case Report and Systematic Review of Literature. Mycopathologia. 2021, 186(2): 289-298. doi: 10.1007/s11046-021-00528-2.
(7). Morán Blanco JI, Alvarenga Bonilla JA, Homma S, Suzuki K, Fremont-Smith P, Villar Gómez de Las Heras K. Antihistamines and azytrhromycin as a treatment for COVID-19 on primary health care- a retrospective observational study in elderly patients. Pulmonary Pharmacology & Therapeutics 67. (2021) 101989.
(8) Puigdellívol-Sánchez. A, Influenza Vaccination, ACEI and ARB in the Evolution of SARS-Covid19 Infection. https://clinicaltrials.gov/ct2/show/NCT04367883. Accedido 25/5/2021.
(9) Juanes-González M, Calderón-Valdiviezo A, Losa-Puig H, González-Salador M, Valls-Roig R, León-Pérez M, Pueyo-Antón L, Lozano-Paz C, Franco-Romero M, Puigdellívol-Sánchez A. Hospitalizations for COVID19, and safety of Angiotensin Converter Enzyme Inhibitors and Angiotensin Receptor Blockers. Jornades Catalanes d’Hipertensió Arterial. Barcelona- Reunión virutal. 2 de diciembre de 2020.
(10). Mayer MA, Vidal-Alaball J, Puigdellívol-Sánchez A6, Francesc X Marín- Gomez FX, Leis A1, Mendioroz Peña J. Clinical Characterization of Patients With COVID-19 in Primary Care in Catalonia: Retrospective Observational Study. JMIR Public Health Surveill. 2021 Feb 8;7(2):e25452. doi: 10.2196/25452.