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Trial - NCT04549376


Column Value
Trial registration number NCT04549376
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04549376

First author
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

Prof Sk Nurul Fattah Rumi

Contact
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

Mostafa Kamal Arefin, arefin61dmc@gmail.com (PI email not reported)

Registration date
Last imported at : Nov. 2, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-16

Recruitment status
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - age: 15-90 years - either gender - patients diagnosed with covid-19 disease by rt-pcr - have confirmed covid-19 symptoms and symptom onset within the past 10 days - capable of using a nasal spray device and perform nasal irrigation required by the study - willing to participate

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- patient with known sensitivity to pvp-i aqueous antiseptic solution or any of its listed excipients - previously diagnosed thyroid disease - patients with chronic renal failure (stage ≥3 by estimated glomerular filtration rate (egfr) modification of diet in renal disease( mdrd) - patients with acute renal failure (kdigo ≥stage 2: creatinine ≥2 x baseline) - pregnant and lactating mother - current requirement for invasive or non-invasive ventilation or planned within next 6 hours.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

DR. MALA KHAN

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

15

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

90

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Bangladesh

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Proportion of COVID-19 positive cases following intervention

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "0.4%;NI", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "0.5%;NI/NS", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "0.6%;NI/NS", "treatment_id": 1015, "treatment_name": "Povidone-iodine", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]