Created at Source Raw Value Validated value
Jan. 13, 2022, 11 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "CIMAvax-EGF group (Experimental). The patients will receive 8 administrations of the product. Every administrationwill have a dose of 2.4 mg of the active principle of the therapeutic vaccine CIMAvax-EGF\u00ae (rhEGF-rP64k conjugate) in 1.2 mL of the injection (vaccine in aqueous phase plus Montanide ISA 51 VG) intramuscularly. The total dose will be divided into 4 subdoses; equivalent to 0.6 mg of EGF at each site of inoculation (both deltoid regions and both glutes). During the induction phase they will receive 4 administrations; one every 14 days. They will then receive 4 doses during the maintenance phase; one dose every 28 days; until 6 months of treatment are completed. Patients in this group will additionally receive the best supportive therapy available; which may include: steroids (depending on the type of respiratory disorder and medical criteria; without exceeding a total daily dose of 60 mg / day for 14 days and / or weekly gradual reduction); bronchodilators; antibiotics in case of infection; hypotensive drugs in case of pulmonary hypertension; medicines for heart failure in case of cor pulmonale; oxygen therapy and / or pulmonary rehabilitation.Control group: Patients in this group will receive the best supportive therapy available; which may include: steroids (depending on the type of respiratory disorder and medical criteria; without exceeding a total daily dose of 60 mg / day for 14 days and / or weekly gradual reduction); bronchodilators; antibiotics in case of infection; hypotensive drugs in case of pulmonary hypertension; medicines for heart failure in case of cor pulmonale; oxygen therapy and / or pulmonary rehabilitation.In each group the patients will be divided into two subgroups:Subgroup 1: Patients with post-COVID-19 pulmonar;Immunotherapy; Active;Epidermal Growth Factor;Injections; Intramuscular;CIMAvax-EGF", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "2,4 mg;8;4 doses every 14 days then 4 doses every 28 days;IM", "treatment_id": 1094, "treatment_name": "Regf-p64k/montanide isa 51 vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]

June 26, 2021, 5:30 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "CIMAvax-EGF group (Experimental). The patients will receive 8 administrations of the product. Every administrationwill have a dose of 2.4 mg of the active principle of the therapeutic vaccine CIMAvax-EGF\u00ae (rhEGF-rP64k conjugate) in 1.2 mL of the injection (vaccine in aqueous phase plus Montanide ISA 51 VG) intramuscularly. The total dose will be divided into 4 subdoses; equivalent to 0.6 mg of EGF at each site of inoculation (both deltoid regions and both glutes). During the induction phase they will receive 4 administrations; one every 14 days. They will then receive 4 doses during the maintenance phase; one dose every 28 days; until 6 months of treatment are completed. Control group: Conventional treatment for this type of postCOVID-19 disorder in Cuba for the duration of the study. This treatment may include bronchodilator drugs; steroids; oxygen therapy; hypotensive drugs in case of pulmonary hypertension and respiratory rehabilitation; among others considered by the specialized personnel in the care of these patients.In each group the patients will be divided into two strata: Stratum 1: Patients with pulmonary fibrosis Stratum 2: Patients with any other respiratory disorder without pulmonary fibrosis;Immunotherapy; Active;Epidermal Growth Factor;Injections; Intramuscular;CIMAvax-EGF", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]