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临床试验/NCT05119348
NCT05119348已完成不适用

Transmission of COVID19 in Crowded Environments

Desmond Tutu HIV Foundation1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2020年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
245
试验地点
1
主要终点
SARS-CoV-2 Infection

研究概览

简要总结

South Africa recorded it's first coronavirus disease 2019 (COVID19) case on March 5, 2020. In response to the COVID19 outbreak World Health Organisation recommendations, South Africa implemented non-pharmaceutical recommendations. The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. The investigators will conduct a randomised controlled trial to investigate the effect of an infection mitigation intervention to assess the effect on household transmission of severe acute respiratory syndrome (SARS) coronavirus (CoV) 2 in household settings with an index patient diagnosed SARS-CoV-2 positive.

详细描述

The major risk mitigation factors recommended by World Health Organisation and others - physical distancing and hygiene - are extremely difficult to implement in much of Africa. Newly diagnosed SARS-CoV-2 index patients will be identified and recruited from a mobile clinic and local community clinics conducting SARS-CoV-2 testing. Index cases and their households will be invited to enroll. The study design is a type 2 hybrid cluster (household) randomised controlled trial, with outcomes assessed on index patients and their household contacts. 120 consecutively newly diagnosed index patients (GeneXpert severe acute respiratory syndrome coronavirus 2 PCR) and up to 6- 8 household contacts will be invited to participate in the trial as part of the prospective observational study evaluating transmission and symptoms. After completing consent, households will be randomised in a 1:1 ratio in blocks of 10 (60 households per group). Klipfontein is a resource-limited, densely populated, high HIV/tuberculosis disease burden areas in Cape Town. Newly diagnosed COVID19 cases will be identified from two sources: screening conducted in Desmond Tutu Health Foundation mobile screening units and local public sector clinics working closely with Desmond Tutu Health Foundation. Consecutive cases (n=120 cases and households) will be invited to participate in the randomised trial and prospective longitudinal follow up of up to 6- 8 household contacts. The contacts will be followed up after informed consent to SARS-CoV-2 screening, symptomatic questionnaires weekly up to 1 month. After enrolment, the household will be randomised to the infection mitigation intervention or enhanced usual care messaging. Baseline demographic, household characteristics questionnaire will be administered, and each household occupant invited to participate. Following consent procedures, household contacts (HHC) will be screened at baseline and weekly for 4 weeks for evidence of COVID19 infection. Specifically, the research team will conduct SARS-CoV-2 GeneXpert PCR testing and antibody serology. They will collate self- administered daily symptom checks on a weekly basis. The investigators will recruit 120 households over 1-11 months. The investigators will initiate a prospective longitudinal follow up of the household contacts of each case for 4 weeks in each case.

The investigators will calculate proportion of SARS-CoV-2 transmission from index cases in each household over 4- week period and describe the proportion of symptomatic and asymptomatic SARS-CoV-2 infection in a high density, low resourced community. Investigate the impact of the infection mitigation intervention by comparing incidence in households randomised to intervention versus standard of care. Secondary outcomes for the trial will include clinical outcomes (hospitalisations, death), linkages to care for people, psychosocial functioning, and stigma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

The investigators were not made aware of participants study condition.

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •recently diagnosed SARS-CoV-2 positive
  • •Individual >12 years
  • •Able to give assent if <18 years with parental/guardian consent
  • •Able to give consent> 18 years
  • •Self-isolating at home at the time of COVID diagnosis

排除标准

  • •<12 years
  • •Unable to give consent

研究组 & 干预措施

Stop coronavirus (STOPCOV)

Experimental

A fieldworker will deliver the STOPCOV pack and personal protective equipment at baseline. The fieldworker will communicate with intervention households daily, delivering STOPCOV hygiene information.

干预措施: STOPCOV (Other)

Control

No Intervention

Participants received no additional messaging about managing COVID19 in the household.

结局指标

主要结局

SARS-CoV-2 Infection

时间窗: 4 weeks

Number of participants with positive SARS-CoV-2 PCR result

次要结局

  • COVID19 Symptoms(4 weeks)

研究者

发起方
Desmond Tutu HIV Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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