Saliva PCR in Pregnant Women with COVID-19

Completed

• Conditions: Coronavirus Disease 2019 (COVID-19) Pneumonia

• Registration Number: NCT06735300
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

Abstract: Objectives We aim to study the relative viral load using saliva polymerase chain reaction among pregnant women treated with Paxlovid. Methods Pregnant women with coronavirus disease 2019 were allocated to two groups: those receiving Paxlovid and those receiving no antiviral agents. We compared the nasopharyngeal and salivary relative viral loads and their changes in saliva specimens. Results Among the 38 pregnant women, seventeen received Paxlovid, and 21 received no antiviral agents. The viral cycle threshold value of saliva was significantly higher than that from nasopharynx, with a median ± interquartile range of 26.44 ± 7.68 versus 17.6 ± 9.6 in the Paxlovid group (p = 0.005). Following treatment, the Paxlovid group showed a significant decrease in relative saliva viral load (cycle threshold value on Day 4/Day 5 minus Day 0) compared to the non-antiviral group (13.40 ± 5.64 versus -1.59 ± 9.63, p = 0.021). The detection rate of coronavirus disease 2019 using salivary polymerase chain reaction was 81.6% (31/38). Conclusions This study showed that saliva is a useful diagnostic tool for coronavirus disease 2019 in pregnant women, and a significant decrease in the relative viral load of saliva was observed in those treated with Paxlovid.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-10-07
• Study Completion: 2022-10-07
• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• This study enrolled pregnant women admitted to NCKUH 70 who tested positive for COVID-19 by real-time reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swab specimens. After providing the potential benefits and associated risks of antiviral treatment with Paxlovid, patients made a well-informed decision about whether or not to receive Paxlovid (300/100 mg nirmatrelvir/ritonavir, Pfizer Inc., USA) twice daily for 5 days.

Exclusion Criteria

• Pregnant women were excluded if the time interval between the onset of symptoms and admission to our hospital was greater than seven days, in the case of insufficient saliva samples, or if any antiviral-related agents were administered, such as remdesivir, glucocorticoids, or interleukin-6 receptor antagonists.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary viral load	From enrollment to the end of treatment at 7 days	The amount of decrease in salivary viral load after taking Paxlovid

Trial Locations

Locations (1)

National Cheng 68 Kung University Hospital; 🇨🇳 Tainan, Taiwan